ophthalmology update - cleveland clinic · 2 ophthalmology update | summer 2008 study examines...

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A Cleveland Clinic research team has developed the first animal model of age-related macular degeneration (AMD) that will enable researchers to study the development and progression of AMD and conduct pre-clinical testing of new therapeutics. The research team, led by Joe G. Hollyfield, PhD, Cleveland Clinic Cole Eye Institute, modified specific proteins found in mouse blood so that the mouse’s immune system was forced to mount a response. This response causes the mouse to display characteristics of AMD in a short amount of time. “More than 8 million Americans are living with vision loss caused by AMD and 250,000 new cases are diagnosed each year. The discovery of the animal model of AMD presents a significant opportunity to efficiently and effectively develop and test novel therapies to both prevent the disease and slow vision loss,” says Dr. Hollyfield. “Research conducted today may one day help find a cure for this progressive disease.” Dr. Hollyfield and his team immunized mice with mouse serum albumin adducted with a specific oxida- tion fragment of the long chain fatty acid DHA that were found in earlier studies from this group to be localized in drusen from AMD donor eye tissues and in plasma samples from AMD patients. The immunized mice developed antibodies to this oxidation fragment, deposited complement in the outer eye wall, accumu- lated drusen below the retinal pigment epithelium and showed features of geographic atrophy. For more information, contact Dr. Joe Hollyfield at [email protected]. Age-Related Macular Degeneration Animal Model Discovered by Cleveland Clinic Researchers Cole Eye Institute SUMMER 2008 Ophthalmology Update Joe G. Hollyfield, PhD Study Examines LUCENTIS ® in Patients with DME Page 2 Small Choroidal Melanoma: Treat or Observe? Page 3 Spectral OCT: Quicker, Better Diagnosis for Retinal Disease Page 4 Rare Peters’ Anomaly Case Successfully Treated with Bilateral Corneal Transplantation Page 6

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Page 1: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

A Cleveland Clinic research team has developed the first

animal model of age-related macular degeneration (AMD)

that will enable researchers to study the development and

progression of AMD and conduct pre-clinical testing of

new therapeutics.

The research team, led by Joe G. Hollyfield, PhD,

Cleveland Clinic Cole Eye Institute, modified specific

proteins found in mouse blood so that the mouse’s

immune system was forced to mount a response. This

response causes the mouse to display characteristics

of AMD in a short amount of time.

“More than 8 million Americans are living with vision

loss caused by AMD and 250,000 new cases are

diagnosed each year. The discovery of the animal model

of AMD presents a significant opportunity to efficiently

and effectively develop and test novel therapies to both

prevent the disease and slow vision loss,” says Dr. Hollyfield.

“Research conducted today may one day help find a cure

for this progressive disease.”

Dr. Hollyfield and his team immunized mice with

mouse serum albumin adducted with a specific oxida-

tion fragment of the long chain fatty acid DHA that

were found in earlier studies from this group to be

localized in drusen from AMD donor eye tissues and in

plasma samples from AMD patients. The immunized

mice developed antibodies to this oxidation fragment,

deposited complement in the outer eye wall, accumu-

lated drusen below the retinal pigment epithelium

and showed features of geographic atrophy.

For more information, contact Dr. Joe Hollyfield at

[email protected].

Age-Related Macular Degeneration Animal Model Discovered by Cleveland Clinic Researchers

Cole Eye Institute summer 2008

Ophthalmology Update

Joe G. Hollyfield, PhD

Study Examines LUCENTIS® in Patients with DME

Page 2

Small Choroidal Melanoma: Treat or Observe?

Page 3

Spectral OCT: Quicker, Better Diagnosis for Retinal Disease

Page 4

Rare Peters’ Anomaly Case Successfully Treated with Bilateral Corneal Transplantation

Page 6

Page 2: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

2 Ophthalmology Update | Summer 2008

Study Examines LUCENTIS® in Patients with DME

Diabetic macular edema (DME) is the leading cause of

vision loss among working adults. Laser grid photoco-

agulation is currently considered the standard of care for

those with clinically significant DME despite findings

that it provides limited improvement in vision. The

only alternative is the use of periocular and intraocular

steroids. Unfortunately, numerous studies have reported

a high rate of cataract progression and development of

glaucoma following use of intraocular steroids necessitat-

ing surgical intervention. Thus, an effective alternative

treatment with a low side effect profile has not been

found with steroids.

At the Cleveland Clinic Cole Eye Institute, Rishi P.

Singh, MD, and colleagues are currently enrolling

patients in two national, multicenter Phase III trials

studying the safety and effectiveness of intraocular

injections of ranibizumab injection (LUCENTIS®) in

patients with DME.

The trials are called RIDE (A Study of Ranibizumab

Injection in Subjects With Clinically Significant

Macular Edema With Center Involvement Second-

ary to Diabetes Mellitus) and RISE (A Study of

Ranibizumab Injection in Subjects with Clinically

Significant Macular Edema With Center Involvement

Secondary to Diabetes Mellitus Studies). Each of these

trials is looking to enroll about 360 patients at 70

centers in the United States. Participants must be at

least 18 years of age and have macular edema as a

result of type 1 or type 2 diabetes.

“Other phases were successful in terms of improving vi-

sion in this group of working adults,” explains Dr. Singh.

“We took on this study to help patients here because

currently there is no good alternate treatment.”

The Ranibizumab for Edema of the Macula in Diabetes

(READ Study) tested the drug with 20 DME patients

at Wilmer Eye Institute, each receiving five injections

of ranibizumab given at baseline, then at 1, 2, 4 and

6 months. Patients were followed for 12 months. The

visual acuity improved by 12 letters on average (range

7-17 letters) at the 12-month time point.

LUCENTIS, manufactured by Genentech, Inc., is

an antibody fragment designed to bind to and inhibit

vascular endothelial growth factor, a protein that is

believed to play a critical role in angiogenesis. It was ap-

proved by the U.S. FDA in June 2006 for the treatment

of neovascular (wet) age-related macular degeneration.

Phase III clinical trials further evaluating the drug for

DME and retinal vein occlusion are ongoing.

Both the RIDE and RISE trials, which began in May 2007,

will primarily measure the proportion of subjects who gain

at least 15 letters in BCVA compared with baseline.

For more information on Cole Eye Institute’s involve-

ment in these trials or to enroll a patient, please email

Dr. Rishi Singh at [email protected].

Rishi P. Singh, MD

“Other phases were successful in terms

of improving vision in this group of work-

ing adults. We took on this study to help

patients here because currently there is

no good alternate treatment.”

Page 3: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

clevelandclinic.org/OUSummer 3

Investigators at Cleveland Clinic Cole Eye

Institute are planning an international multi-

center randomized trial to evaluate the impact

of deferred treatment on the risk of metastasis

in patients with small choroidal melanoma.

Small Choroidal Melanoma: Treat or Observe?

Enrollment of approximately 550 patients will begin

in July 2008, according to Arun Singh, MD, Director of

Ophthalmic Oncology at Cole Eye Institute. Dr. Singh

will be the principal investigator; Andrew P. Schachat,

MD, Cole Eye Institute Vice Chairman of Clinical Affairs,

will be co-investigator.

The treatment approach for choroidal melanoma was con-

troversial until a study funded by the National Institutes

of Health (the Collaborative Ocular Melanoma Study, or

COMS) was completed in 2003, says Dr. Singh. That study

classified tumors as small, medium or large and focused

on the medium and large lesions; small melanomas were

assessed in an observational study but not included in any

randomized treatment protocol.

In the COMS study, 63 percent of tumors classified as

small melanoma did not grow during the five-year study

period. This suggests that the small melanoma, as clas-

sified in the COMS, were either large nevi or melanoma

that did not grow. “Therefore, the true nature of these

lesions is not known and to classify them as small

choroidal melanoma is misleading,” Dr. Singh notes.

“Perhaps labeling them as choroidal indeterminate

melanocytic lesion is preferable.”

“We are still stuck with the uncertainty as to whether

observation is the right thing to do, or whether you treat

patients immediately because you believe the tumor is

going to grow and it is best to treat it right away,” he

explains. “The option that many people would choose is

to wait and see if it grows and then treat. But if you wait

to treat, what if the tumor starts to spread? Some people

may not want to take that risk.”

The proposed study will address the “unfinished busi-

ness” of COMS by randomly assigning patients to either

deferred treatment (planned observation for growth prior

to treatment) or prompt treatment (within 30 days of en-

rollment) with radiotherapy. For patients in the deferred

treatment group, growth will be defined as an increase

in basal diameter of 0.5 mm or height of at least 0.3 mm,

based on the treating physician’s observations.

All patients will be followed for at least five years. Out-

come measures will include disease-free survival, rate

of globe retention, rate of tumor growth (in the deferred

treatment group only), rate of tumor control and visual

acuity. Inclusion and exclusion criteria and other aspects

of the study will be very similar to those of the National

Institutes of Health study so that the data from the analy-

sis of small lesions will fit in with that of the earlier study,

Dr. Singh says.

The data will be analyzed every year to generate statistics

that will tell investigators whether the trial is effective or

futile, either of which would prompt discontinuation of

the study, or whether the results are between those two

extremes and the study should continue. The study should

generate data that could be used to develop evidence-based

guidelines for the treatment of indeterminate choroidal

melanocytic lesions.

To register a patient for this study, call 216.445.9479

or email [email protected].

Small choroidal melanoma with orange

pigmentation and subretinal fluid.

Arun D. Singh, MD

Page 4: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

The next generation of optical coherence tomography (OCT) technology, or spectral domain OCT,

continues to evolve – revolutionizing diagnosis, monitoring and treatment for retinal disease.

Spectral OCT: Quicker, Better Diagnosis for Retinal Disease

At Cleveland Clinic Cole Eye Institute, retinal specialist

Peter K. Kaiser, MD and colleagues are collaborating with

numerous manufacturers to create software, algorithms

and otherwise develop the technology further.

“The main difference between time domain OCT and

spectral OCT is acquisition speed,” Dr. Kaiser explains.

A typical time domain B-scan captures 512 A-scans in

one second vs. the up to 40,000 A-scans per second using

spectral domain OCT. The massive speed increase offers

the ability to better map the retina.

This difference translates into the ability to catch early mac-

ular edema or not, or recurrence of choroidal neovascular-

ization (CNV) in age-related macular degeneration (AMD).

“With time domain OCT, to evaluate the macula you get six

linear scans each separated by 30 degrees,” says Dr. Kaiser,

who is the founder and director of the Digital OCT Read-

ing Center (DOCTR) at the Cole Eye Institute. “In between

those scans, there’s really a lot of space. So, if there’s a little

bit of edema or fluid there, it won’t be picked up.”

In contrast, spectral domain OCT allows clinicians to im-

age the entire macula with a 6 mm × 6 mm cube scan and

image all points inside it. “While time domain OCT could

do a similar scan, it would take 20 minutes. This isn’t

feasible because of the patient’s eye movement during this

time,” Dr. Kaiser says. “With spectral domain OCT, this

scan could be completed in less than a minute.” This gives

a complete view of the retina and no areas are missed.

Peter K. Kaiser, MD

Spectral OCT

images help

diagnose, treat

and manage retinal

disease more

effectively.

4 Ophthalmology Update | Summer 2008

Page 5: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

Another advantage of spectral OCT is higher axial resolu-

tion. The 5- to 7-µm resolution that can be achieved with

a spectral domain OCT means that more detailed infor-

mation is available in these scans, he says. For instance, in

a case of central serous retinopathy, spectral domain OCT

is able to pick up some debris in the serous detachment

that isn’t visible on time domain OCT images, or image

the photoreceptor inner and outer segments in patients

with retinal degenerations.

Because spectral domain OCT can quickly scan the

macula, a new 3-D view is also possible, Dr. Kaiser says.

This allows a depth of data that can be segmented that

is not possible with 2-D time domain OCT images.

“With these new 3-D views, we’ll gain more insight

into retinal pathology and perhaps see key details that

allow us to diagnose disease that would have otherwise

remained undetectable,” he explains.

This technology also helps improve visit-to-visit regis-

tration and comparison accuracy through total patient

recall and repeat scan functions, he says. This is espe-

cially important for participation in clinical studies or

following patients with diabetes or AMD.

“Together with its speed, resolution and low acquisition

times, these advantages are helping us diagnose, treat and

manage disease more effectively,” he concludes.

For more information about the use of spectral

OCT at Cole Eye Institute, email Dr. Peter Kaiser at

[email protected].

Fundus image with retinal thickness map

Retinal thickness map Internal limiting membrane (ILM) map

OCT images

“With these new 3-D views, we’ll gain more

insight into retinal pathology and perhaps

see key details that allow us to diagnose

disease that would have otherwise

remained undetectable.”

clevelandclinic.org/OUSummer 5

Retinal pigment epithelium (RPE) map

Page 6: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

Most affected patients have bilateral manifestations

and many have additional ocular abnormalities, such

as myopia, aniridia, coloboma of the iris, nystagmus,

microphthalmos, persistent hyperplastic primary

vitreous (PHPV) and optic disk hypoplasia.

Elias I. Traboulsi, MD, Pediatric Ophthalmology and

Strabismus, Cleveland Clinic’s Cole Eye Institute,

recently performed bilateral corneal transplantation

on an infant who was blind from Peters’ anomaly.

The baby’s mother was initially told by several local oph-

thalmologists that nothing could be done for her daughter.

She then contacted Dr. Traboulsi’s office. The child was a

few months old at the time and he decided that observation

was the best initial course, in hopes that the hazy corneas

would clear on their own. He also conducted a thorough

evaluation to confirm that no other part of the ocular

system was affected.

“We were trying to avoid corneal transplantation at all

costs due to the high failure rates in children, the need for

long-term use of topical steroids and the increased risk of

glaucoma later in life,” he recalls.

“The haze did not resolve, but fortunately the iris and

the lens were not adherent to the back of the cornea,” Dr.

Traboulsi continues. “We decided to perform a transplant

in one eye while continuing to observe the other one.”

The surgery went extremely well and the baby’s family

raved about the transformation in the child’s behavior.

The fellow eye received a transplant several months later.

Both have healed well and tapering of the steroids to a

long-term maintenance dose is under way.

Dr. Traboulsi explains that the management of corneal

transplants in children is different from in adults. In par-

ticular, sutures are removed much earlier (at 2 to 3 months)

to reduce the risk of the cornea becoming vascularized.

This is safe, as the hastened healing that is naturally present

in children limits the risk of the wound opening. However,

the sutures have to be removed under anesthesia.

Follow-up

The ability to address Peters’ anomaly with corneal trans-

plantation represents a rare area of expertise for an ophthal-

mic program to offer. However, Dr. Traboulsi believes that

the improvements in the child’s life legitimize the effort.

The visual prognosis for babies with Peters’ anomaly can be challenging given that they can have

a central corneal opacity with associated abnormalities of corneal development and iris adhesions

to the cornea, as well as cataract and glaucoma.

Rare Peters’ Anomaly Case Successfully Treated with Bilateral Corneal Transplantation

Elias I. Traboulsi, MD

A bilateral corneal

transplantation at

Cole Eye Institute

restored vision

to this infant who

was blind from

Peters’ anomaly.

6 Ophthalmology Update | Summer 2008

Page 7: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

The girl’s mother recalls that it was obvious right away

that her newborn could not see, and the girl’s develop-

ment was clearly limited by it. “She wears glasses now and

is about six months behind cognitively and physically. But

she is very intelligent and now that she can see, she has

quickly figured out how to do more things for herself,”

she says about the nearly 1 year old.

“She reaches for things now, she will follow you around.

Before she mostly just sat in my lap and didn’t like to ever

be left alone,” the mother recalls. “Now she has a mind

of her own and she is so much more active. We are very

grateful to Dr. Traboulsi for making her who she is. It’s

been a miracle for us.”

The child is still learning to crawl and walk but progress

on both has sped up since she gained her vision. She does

have other physical problems, which are presumed to be

linked to her genetic disorder − a missing piece of her

sixth chromosome and an extra one at her 18th chromo-

some. These include borderline scoliosis and a tethered

cord in her back; the specialists she sees regularly include

cardiologists, orthopedists and a geneticist.

Peters’ anomaly

A very rare condition, Peters’ anomaly is manifested in

the first trimester of pregnancy, during the formation of

the anterior chamber. Ocular abnormalities are generally

noted at birth, although affected infants can be asymp-

tomatic or may have other ocular or systemic anomalies.

The cause is unknown; genetic factors, environmental

factors, or both may be involved.

In a study co-authored with Irene H. Maumenee, MD,

and published in Archives of Ophthalmology in 1992,

Dr. Traboulsi reviewed the clinical findings in 29

patients with Peters’ anomaly. There was developmental

delay in 15 patients, congenital heart disease in eight,

external ear abnormalities in five, structural defects of the

central nervous system in four, genitourinary malforma-

tions in four, cleft lip/palate in three, hearing loss in

three, spinal defects in two, and single cases of other less

common defects. One patient had fetal alcohol syndrome;

one, Pfeiffer’s syndrome; and one, short stature, ulnar

hypoplasia and joint laxity.

Colobomatous microphthalmia was present in seven

patients, and persistent hyperplastic primary vitreous

in three patients. Ten patients developed glaucoma, and

three had retinal detachment unrelated to ocular surgery.

In Peters’ anomaly, central or paracentral corneal opacity

is present; it can involve the entire cornea. In type 1, the

lens may or may not be cataractous; however, the lens

does not adhere to the cornea. In type 2, the lens is cata-

ractous and adheres to the cornea.

In another study, published in Ophthalmic Genetics

in 1994, Dr. Traboulsi and his co-authors reviewed the

charts of 22 patients with Peters’ anomaly. Various surgi-

cal procedures were performed on 30 eyes of 18 patients

(mean number of procedures = 3.3 per eye). Follow-up

averaged six years.

Visual acuity varied widely, with six eyes being 20/400 or

better, and 11 having no light perception. Concomitant

or secondary glaucoma required a greater number of sur-

gical procedures (4.1 vs. 3.4) per eye and was associated

with a poorer visual outcome. No eyes with glaucoma had

visual acuity better than 20/400.

In bilaterally operated patients, visual results in one eye

were independent of the outcome of the fellow eye. The

range of visual acuity in bilaterally operated patients was

similar to the vision in those operated unilaterally.

Since that study, several other studies have confirmed

the guarded prognosis in patients with Peters’ anomaly

who undergo corneal transplantation; yet many need the

procedure and it is successful in restoring vision in some.

Contact Dr. Elias Traboulsi at [email protected].

“Now she has a mind of her own and she is so much more active. We are very

grateful to Dr. Traboulsi for making her who she is. It’s been a miracle for us.”

clevelandclinic.org/OUSummer 7

Page 8: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

Age-Related Macular Degeneration

A 24-month randomized, double-masked, controlled, multicenter, phase IIIB study assessing safety and efficacy of verteporfin (Visudyne®) photodynamic therapy administered in conjunction with ranibizumab (LucentIs™) versus ra-nibizumab (LucentIs™) monotherapy in patients with subfoveal choroidal neo-vascularization secondary to age-related macular degeneration (DenALI)

Objective: This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes com-pared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.

Contact: Rishi P. Singh, MD at 216.445.9497 or Lynn Bartko, RN at 216.444.7137

A Phase I open-label, dose escalation trial of ReDD14nP delivered by a single intra-vitreal injection to patients with choroidal neovascularization secondary to exuda-tive age-related macular degeneration (QuARK)

Objective: This is an open-label, dose esca-lation study in which patents will receive a single intravitreal injection of REDD14NP. The primary objective of the study is to de-termine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection.

Contact: Peter K. Kaiser, MD at 216.444.6702 or Lynn Bartko, RN at 216.444.7137

Retinal Vein Occlusion

A Phase III, Multicenter, Randomized, sham-controlled study of the efficacy and safety of Ranibizumab compared with sham in subjects with Macular edema secondary to central Retinal Vein Occlusion (cRVO)

Objective: This study is a Phase III, multi-center, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab com-pared with sham injections in subjects with macular edema secondary to central retinal vein occlusion (CRVO). Approximately 390 subjects with CRVO will be randomized at approximately 70 investigational sites in the United States.

Contact: Rishi P. Singh, MD at 216.445.9497 or Gail Kolin, RN at 216.445.4086

Diabetic Retinopathy

Vascular Remodeling and effects of Angiogenic Inhibition in Diabetic Retinopathy (nIH)

Objective: This study will test whether the pattern of the retinal vasculature changes in patients with different levels of dia-betic retinopathy can be quantified using computerized image analysis. In addition, the study will evaluate whether new drugs to treat diabetic retinopathy will be able to reverse these vascular changes.

Contact: Peter K. Kaiser, MD at 216.444.6702 or Ly Pung, RN at 216.445.6497

A Phase III, Double-Masked, Multi-center, Randomized, sham-controlled study of the efficacy and safety of Ranibizumab Injec-tion in subjects with clinically significant Macular edema with center Involvement secondary to Diabetes Mellitus (DMe)

Objective: This study is a Phase III, double-masked, multicenter, randomized, sham-controlled study of the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2). Approximately 366 subjects will be randomized at approximately 70 investigational sites in the United States.

Contact: Rishi P. Singh, MD at 216.445.9497 or Laura Holody, COA at 216.445.3762

uveitis

An 8-Week, Multicenter, Masked, Random-ized trial to Assess the safety and efficacy of 700 µg and 350 µg Dexamethasone Pos-terior segment Drug Delivery system Appli-cator system compared with sham DeX Ps DDs Applicator system in the treatment of non-Infectious Ocular Inflammation of the Posterior segment in Patients with Interme-diate uveitis (POsuRDeX uVeItIs)

Objective: This study will evaluate the safety and efficacy of the 700 µg DEX PS DDS Applicator System (700 µg dexamethasone) compared with the 350 µg DEX PS DDS Applicator System (350 µg dexamethasone) in the treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate uveitis.

Contact: Careen Lowder, MD, PhD at 216.444.3642 or Ly Pung, RN at 216.445.6497

CLINICAL TRIALSThe following studies are currently enrolling. All studies have been approved by the Institutional Review Board.

8 Ophthalmology Update | Summer 2008

Page 9: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

Pediatric Eye Disease

Infant Aphakia treatment study (IAts)

Objective: The primary purpose of this study is to determine whether infants with a unilateral congenital cataract are more likely to develop better vision following cataract extraction surgery if they undergo primary implantation of an intraocular lens or if they are treated primarily with a contact lens. In addition, the study will compare the occur-rence of postoperative complications and the degree of parental stress between the two treatments.

Contact: Elias Traboulsi, MD at 216.444.4363 or Sue Crowe, RN at 216.445.3840

Genetics

studies of the Molecular Genetics of eye Diseases (BRtt)

Objective: The objective of this project is to study the molecular genetics of ophthal-mic disorders through the compilation of a collection of DNA, plasma and eye tissue samples from patients and from families with a broad range of eye diseases and malformations.

Contact: Elias Traboulsi, MD at 216.444.4363 or Patrice Nerone, RN at 216.445.9886

A Multicenter study to Map novel Genes for Fuchs’ endothelial corneal Dystrophy (Fuchs’)

Objective: This is a nationwide study to ex-plore how FECD runs in families. Approxi-mately 500 families will be recruited in the study from 2006 to 2009. Data from the participants will be used to find the gene(s) associated with the disease.

Contact: William Dupps, MD, PhD at 216.444.8396 or Ly Pung, RN at 216.445.6497

Cornea

Posterior Lamellar endothelial Keratoplasty study (PLeK)

Objective: The purpose of this study is to determine if a partial-thickness corneal transplant known as posterior lamellar en-dothelial keratoplasty (PLEK) can improve vision in diseases affecting the posterior cornea with minimal optical side effects.

Contact: David Meisler, MD at 216.444.8102 or Laura Holody, COA at 216.445.3762

us clinical study of the AcRYsOF Angle-supported Phakic IOL

Objective: The objective of this study is to evaluate the safety and effectiveness of the ACRYSOF Angle-Supported Phakic IOL when used to correct high myopia. The first phase of this study has been completed, and we are currently enrolling patients in a second phase of this study.

Contact: Ronald Krueger, MD at 216.444.8158 or Laura Holody, COA at 216.445.3762

The following studies have completed patient enrollment in the last year at Cole Eye Institute and are in follow up.

• A 2 year, multicenter, randomized, controlled, masked, dose-finding trial to assess the safety and efficacy of multiple intravitreal injections of AGN 211745 in patients with subfoveal choroidal neo-vascularization secondary to age-related macular degeneration (SIRIUS)

• An Evaluation of Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15 mg or 30 mg) versus Sham Adminis-tration in Patients at Risk for Developing Sight-Threatening Choroidal Neovascu-larization (CNV) Due to Exudative Age-Related Macular Degeneration (AART)

• An open-label, multicenter extension study to evaluate the safety and toler-ability of Ranibizumab in subjects with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) who have completed the treatment phase of a Genentech-spon-sored Ranibizumab study (HORIZON)

• Protocol B7A-MC-MBCU The effect of Ruboxistaurin on Clinically Significant Macular Edema in patients with Diabetes Mellitus, as assessed by optical coherence tomography (MBCU)

• Protocol B7A-MC-MBDL Reduction in the occurrence of center-threatening Diabetic Macular Edema (MBDL)

clevelandclinic.org/OUSummer 9

Page 10: Ophthalmology Update - Cleveland Clinic · 2 Ophthalmology Update | Summer 2008 Study Examines LUCENTIS® in Patients with DME Diabetic macular edema (DME) is the leading cause of

PROgRaMS In OPhThaLMIC eDuCationPhysicians are invited to attend the following ophthalmic continuing medical education courses at Cleveland Clinic’s Cole Eye Institute.

All courses will be held in the James P. Storer Conference Center on the first floor of the Cole Eye Institute. For more information, contact

Jane Sardelle, program coordinator, at 216.444.2010 or 800.223.2273, ext. 42010, or at [email protected].

Saturday, June 7, 2008 Innovations in Refractive Surgery

Course Directors:

Ronald R. Krueger, MD Refractive Surgery Cleveland Clinic Cole Eye Institute

Steven E. Wilson, MD Cornea and Refractive Surgery Cleveland Clinic Cole Eye Institute

William J. Dupps, Jr., MD, PhD Cornea and Refractive Surgery Cleveland Clinic Cole Eye Institute

Guest Faculty:

Francesco Carones, MD Carones Ophthalmology Centre Milan, Italy

Randall J. Olson, MD Professor and Chairman Director, John A. Moran Eye Center University of Utah School of Medicine Salt Lake City, Utah

Roger F. Steinert, MD UCI Medical Center University of California-Irvine Irvine, Calif.

George O. Waring III, MD, FACS, FRCOpth Emory University Atlanta, Ga.

Description/Objectives:

This program highlights the most notable innovations in refrac-tive surgery in the past few years. Each of these innovations has begun to revolutionize the field of refractive surgery and in doing so has also begun to stir up some controversy. The program will also include debates on three controversial topics in the field: vision correction (laser vs. lens), laser vision cor-rection (surface ablation vs. LaSIK) and presbyopia correction (multifocality vs. movement vs. depth of field).

Participants should be able to indicate whether intraocular benefits outweigh the risks, whether the popular return of surface ablation outweighs the precision of IntraLaSIK and whether technologies using multifocality, movement or depth of field will likely define the future of presbyopia correction.

At the conclusion of this course, participants should be able to identify and characterize the most notable innovations in the field of refractive surgery and describe the pros and cons surrounding their adoption and widespread acceptance. These include:

• advanced ocular imaging for precision diagnosis

• Phakic IOLs for high ametropias

• Collagen crosslinking for keratoectasia

• Mitomycin C vs. smoothing for PRK haze prevention and treatment

• Multifocal IOLs for presbyopia correction

• Femtosecond lasers for safer, more uniform flaps and keratoplasty

• advanced custom laser delivery and registration for aberration reduction

Mark your Calendars !

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June 12-13, 2008 Annual Research, Residents and Alumni Meeting

Course Directors:

Hilel Lewis, MD Chairman, Cole Eye Institute

Careen Y. Lowder, MD, PhD Uveitis Department Cole Eye Institute

Keynote Lecturer:

Yasuo Tano, MD Treasurer, International Council of Ophthalmology President, Asia-Pacific Academy of Opthalmology Professor and Chairman, Department of Ophthalmology Osaka University, Osaka, Japan

Targeted audience:

General ophthalmologists, Cole Eye Institute staff, fellows, residents, alumni and others.

Description/Objectives:

This program provides a scientific forum to present origi-nal, thought-provoking clinical research papers and basic science research of the Cole Eye Institute residents, fellows, staff, alumni and invited ophthalmologists. In addition to the educational aspects of the program and learning about new and ongoing investigations, this event offers an excellent op-portunity to meet current residents, fellows, new faculty and invited ophthalmologists, and make and renew friendships.

• Recognize the most up-to-date concepts and treatments in research and clinical ophthalmology

• Identify current basic science research in AMD

• Review the rationale and status of the most current treatments for uveitic and diabetic macular edema

• Discuss outcomes of complicated glaucoma and cataract surgery

• Describe the latest techniques in refractive surgery

clevelandclinic.org/OUSummer 11

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June 5, 2008 Molecular Pathology of Age-Related Macular Degeneration

Chi-Chao Chan, MD Head, Section of Immunopathology Laboratory of Immunology Director, Histology Core national Eye Institute national Institutes of health Bethesda, Md.

July 17, 2008 Intracellular Trafficking in the Retina: Essential Roads for Vision

David S. Williams, PhD adjunct Professor Department of Pharmacology and Neurosciences University of California, San Diego San Diego, Calif.

September 11, 2008 An Eye on Cancer

Arthur S. Polans, PhD Professor and Associate Director Department of Ophthalmology and Visual Sciences & the University of Wisconsin Eye Research Institute The University of Wisconsin-Madison Madison, Wisc.

October 16, 2008 Development of Novel Therapies for Retinal Degeneration

Robin Ali, BSc, PhD Professor of human Molecular genetics Head, Division of Molecular Therapy Institute of Ophthalmology University College London London, England

November 20, 2008 Aberrant Activity of the Complement System in Age-Related Macular Degeneration

Gregory S. Hageman, PhD Iowa Entrepreneurial Endowed Professor Department of Ophthalmology & Visual Sciences University of Iowa, Carver College of Medicine Iowa City, Iowa

DISTINgUIShED LECTURE series

The Cleveland Clinic Cole Eye Institute is proud to present the 2008 Distinguished Lecture Series, which provides a forum for renowned researchers in the visual sciences to present their latest research findings. This series of lectures will feature advances in many areas of ophthalmic research presented by noted basic and clinical scientists from throughout the world. Ample opportunity for questions and answers will be provided.

Please join us for these insights into ophthalmic research and the promises they hold for patient care. no registration is required; call 216.444.5832 with any questions. One CME credit is available.

all programs will be held in the James P. Storer Conference Center of the Cole Eye Institute from 7 to 8 a.m. attendees should park in the East 102nd Street parking lot (facing the front of the Cole Eye Institute) or the visitor’s parking garage at East 100th Street and Carnegie avenue. We will validate your parking ticket.

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Faculty Disclosure

The Cleveland Clinic Center for Continuing Education has implemented a policy to comply with the current accreditation Council for Continuing Medical Education Standards for Com-mercial Support requiring resolution of all faculty conflicts of interest. Faculty declaring a relevant commercial interest will be identified in the activity syllabus.

aCCreDitation statement

The Cleveland Clinic Center for Continuing Education is

accredited by the Accreditation Council for Continuing

Medical Education to provide continuing medical

education for physicians.

The Cleveland Clinic Center for Continuing Education desig-

nates this educational activity for a maximum of 1.0 Category

1 credit (per meeting) toward the AMA Physician’s Recognition

Award. Each physician should claim only those credits that

he/she actually spent in the activity.

This activity may be submitted for American Osteopathic

Association Continuing Medical Education credit in Category 2.

Aging Eye Summit Series: Focus on Diabetic Retinopathyregister now!

www.preventblindness.net/drsummit

The InterContinental hotel and Conference Center

Cleveland, Ohio

Thursday, June 12, 2008

9:30 am to 3:30 pm

Register today to learn from world-renowned

experts about:

• The status and treatment of diabetes

and diabetic retinopathy

• The latest research and treatment initiatives

• Current strategies for prevention

• Public health perspectives and resources

• Patient perspectives

Seating is limited to the first 150 registrants. Registra-

tion, continental breakfast and lunch are complimentary.

To register and for more information about the Summit,

log on to www.preventblindness.net/drsummit or call

800.301.2020 ext.112

The Summit is for patients, vision researchers, clinicians,

public health and rehabilitation professionals, aging

network professionals, bio-science funders and leaders

from government and the bio-tech industry.

The Aging Eye Summit Series: Focus on Diabetic

Retinopathy is presented by: Cleveland Clinic Cole Eye

Institute, Ohio’s Aging Eye Public Private Partnership

and Prevent Blindness Ohio.

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COLE EyE INSTITUTE staFF

Hilel Lewis, MD

Chairman, Cole Eye Institute

Specialty/Research Interests: Vitreoretinal

surgery for complicated retinal detachment

and trauma, age-related macular degeneration,

diabetic retinopathy, retinal photocoagulation,

instrument development

Office Phone: 216.444.0430

Bela Anand-Apte, MBBS, PhD

Ophthalmic Research Department

Research Interest: angiogenesis

Office Phone: 216.445.9739

John W. Crabb, PhD

Ophthalmic Research Department

Research Interests: age-related macular

degeneration, inherited retinal diseases

Office Phone: 216.445.0425

William J. Dupps, Jr., MD, PhD

Cornea and External Disease Department

Specialty/Research Interests: Cornea,

cataract and refractive surgery

Office Phone: 216.444.8396

Marc A. Feldman, MD

Ophthalmic Anesthesia

Research Interests: Ophthalmic surgery

anesthesia, preoperative assessment,

resident education

Office Phone: 216.444.9088

Richard E. Gans, MD, FACS

Comprehensive Ophthalmology Department

Specialty/Research Interests: Cataract,

glaucoma, diabetes

Office Phone: 216.831.0120

Philip N. Goldberg, MD

Comprehensive Ophthalmology Department

Specialty Interests: Cataract, glaucoma

Office Phone: 216.831.0120

Froncie A. Gutman, MD

Vitreoretinal Department

Specialty/Research Interests: Retinal vascular

diseases, laser therapy, diabetic retinopathy

Office Phone: 216.444.5888

Stephanie A. Hagstrom, PhD

Ophthalmic Research Department

Research Interests: Inherited forms of retinal

degeneration, including macular degeneration

and retinitis pigmentosa

Office Phone: 216.445.4133

Joe G. Hollyfield, PhD

Ophthalmic Research Department

Research Interests: Retinal degeneration,

retinal diseases

Office Phone: 216.445.3252

Peter K. Kaiser, MD

Vitreoretinal Department

Specialty/Research Interests: Vitreoretinal dis-

eases, age-related macular degeneration, retinal

detachment, diabetic retinopathy, endophthalm-

itis, posterior segment complications of anterior

segment surgery

Office Phone: 216.444.6702

Gregory S. Kosmorsky, DO

Neuro-Ophthalmology Department

Specialty Interests: Neuro-ophthalmology,

cataract, refractive surgery

Office Phone: 216.444.2855

Ronald R. Krueger, MD, MSE

Refractive Surgery Department

Specialty/Research Interests: Refractive

surgery, lasers, refractive corneal pathology,

lamellar corneal transplants, investigational

clinical trials

Office Phone: 216.444.8158

Lisa Kuttner-Kondo, PhD

Ophthalmic Research Department

Specialty/Research Interests: Role of the

complement system and its regulation in

age-related macular degeneration

Office Phone: 216.444.9830

Roger H.S. Langston, MD

Cornea and External Disease Department

Specialty Interests: Cornea and external

disease, corneal transplantation

Office Phone: 216.444.5898

Careen Y. Lowder, MD, PhD

Uveitis Department

Specialty/Research Interests: Uveitis,

intraocular inflammatory diseases, pathology

Office Phone: 216.444.3642

Lisa D. Lystad, MD

Neuro-Ophthalmology and Comprehensive

Ophthalmology Departments

Specialty/Research Interests: neurological

disorders, comprehensive ophthalmology

Office Phone: 216.445.2530

Andreas Marcotty, MD

Pediatric Ophthalmology

and Strabismus Department

Specialty Interests: Pediatric ophthalmology,

adult strabismus

Office Phone: 216.831.0120

Shari Martyn, MD

Comprehensive Ophthalmology Department

Specialty Interests: Cataract, glaucoma,

diabetes

Office Phone: 216.831.0120

David M. Meisler, MD

Cornea and External Disease Department

Specialty/Research Interests: Corneal and

external disease, inflammatory and infectious

diseases of the cornea, corneal transplantation,

refractive surgery

Office Phone: 216.444.8102

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COLE EyE INSTITUTE staFF

Michael Millstein, MD

Comprehensive Ophthalmology Department

Specialty Interests: Cataract, glaucoma,

refractive surgery

Office Phone: 216.831.0120

Neal S. Peachey, PhD

Ophthalmic Research Department

Research Interests: Visual loss associated

with hereditary retinal degeneration

Office Phone: 216.445.1942

Julian D. Perry, MD

Oculoplastic and Orbital Surgery Department

Specialty/Research Interests: aesthetic facial

surgery/fat transplantation and repositioning,

acellular human dermal graft matrix, new bovine

hydroxyapatite orbital implant, thyroid eye

disease/rate of strabismus after decompression

surgery for dysthyroid orbitopathy

Office Phone: 216.444.3635

Edward J. Rockwood, MD

Glaucoma Department

Specialty/Research Interests: Glaucoma,

glaucoma laser surgery, combined cataract and

glaucoma surgery, glaucoma filtering surgery

with antimetabolite therapy, glaucomatous optic

nerve damage, congenital glaucoma

Office Phone: 216.444.1995

Allen S. Roth, MD

Comprehensive Ophthalmology Department

Specialty Interests: Corneal transplantation,

refractive surgery, cataract and implant surgery

Office Phone: 216.831.0120

Andrew P. Schachat, MD

Vitreoretinal Department

Vice Chairman of Clinical Affairs

Specialty/Research Interests: age-related

macular degeneration, diabetic retinopathy,

medical retina

Office Phone: 216.444.7963

Jonathan E. Sears, MD

Vitreoretinal Department

Specialty/Research Interests: Pediatric and

adult vitreoretinal diseases, pediatric retinal

detachment, inherited vitreoretinal disorders,

retinopathy of prematurity, other acquired

proliferative diseases

Office Phone: 216.444.8157

David B. Sholiton, MD

Comprehensive Ophthalmology Department

Specialty Interests: Cataract and implant sur-

gery, glaucoma, oculoplastics

Office Phone: 216.831.0120

Arun D. Singh, MD

Ophthalmic Oncology Department

Specialty/Research Interests: retinoblastoma,

uveal melanoma, eyelid and conjunctival tumors

and von hippel Lindau disease

Office Phone: 216.445.9479

Rishi D. Singh, MD

Vitreoretinal Department

Specialty/Research Interests: surgical and

medical treatment of the retina, macula and

vitreous

Office Phone: 216.445.9497

Scott D. Smith, MD, MPH

Glaucoma Department

Specialty/Research Interests: Glaucoma,

cataract, prevention of eye disease, international

ophthalmology, congenital glaucoma

Office Phone: 216.444.4821

Elias I. Traboulsi, MD

Pediatric Ophthalmology and Strabismus

Department, Center for Genetic Eye Diseases

Specialty/Research Interests: Ocular diseases

of children, genetic eye diseases, strabismus,

retinoblastoma, congenital cataracts, childhood/

congenital glaucoma

Office Phone: 216.444.4363

Nadia K. Waheed, MD, MPH

Vitreoretinal Department

Specialty/Research Interests: surgical and

medical treatment of the retina, macula and

vitreous

Office Phone: 216.445.9432

Steven E. Wilson, MD

Cornea and External Disease and

Refractive Surgery Departments

Specialty/Research Interests: Refractive

surgery, corneal healing

Office Phone: 216.444.5887

oPtometrists

David Barnhart, OD

Anita Chitluri, OD

Heather Cimino, OD

Ann Laurenzi, OD

Rosemary Perl, OD

William Sax, OD

Mindy Toabe, OD

Diane Tucker, OD

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Ophthalmology Update, a publication of The Cleveland Clinic Cole Eye Institute, provides information for ophthalmologists about state-of-the-art diagnostic and man-agement techniques and current research.

Please direct any correspondence to:

Steven E. Wilson, MD Cole Eye Institute / i32 The Cleveland Clinic Foundation 9500 Euclid Avenue Cleveland, Ohio 44195

Phone 216.444.5887 Fax 216.445.8475

Director and Chairman Hilel Lewis, MD

Editor-in-Chief Steven E. Wilson, MD

Marketing Manager Bill Sattin, PhD

Marketing Coordinator natalie Weigl

Managing Editor ann Bungo

Art Director Michael Viars

Cleveland Clinic is an independent, not-for-profit, multispecialty academic medical center. It is dedicated to providing quality specialized care and includes an outpatient clinic, a hospital with more than 1,000 available beds, an education division and a research Institute.

Ophthalmology Update is written for physicians and should be relied upon for medical education purposes only. It does not provide a complete overview of the topics covered and should not replace the independent judgment of a physician about the appropriateness or risks of a procedure for a given patient.

Physicians who wish to share this information with patients need to make them aware of any risks or potential complications associated with any procedures.

© The Cleveland Clinic Foundation 2008

08-EYE-003

Cole Eye Institute

9500 Euclid Avenue / AC311

Cleveland, OH 44195

clevelandclinic.org/OUSummer

REFERRaLS

216.444.2020

The Cleveland Clinic Cole Eye Institute Vision Line is your direct link to our staff for prompt physician referral to an ophthalmology subspecialist for consultation and appointments.

OnLInE aCCESS TO YOUR PaTIEnT’S TREaTMEnT PROgRESS

Whether you are referring from near or far, our new eCleveland Clinic service, DrConnect, can streamline communication from Cleveland Clinic physicians to your office. This new online tool offers you secure access to your patient’s treatment progress at Cleveland Clinic. With one-click convenience, you can track your patient’s care using the secure DrConnect website. To establish a DrConnect account, visit eclevelandclinic.org or e-mail [email protected].

SPECIaL aSSISTanCE FOR OUT-OF-STaTE PaTIEnTS

The Cleveland Clinic’s Medical Concierge program is a complimentary service for patients who travel to Cleveland Clinic from outside Ohio. Our patient care representatives facilitate and coordinate the scheduling of multiple medical appointments; provide access to dis-counts on airline tickets and hotels, when available; make reservations for hotel or housing accommodations; and arrange leisure activities. For more information: call 800.223.2273, ext. 55580, visit clevelandclinic.org/services, or email [email protected].