RETINA RESEARCH CENTER

CONTACT Us

Brian B. Berger, M.D.bberger@e-retina.net

Robert W. Wong, M.D. rwong@e-retina.net

Ginger Manhartgmanahrt@e-retina.net 512-454-0138 x203

• Molecular Partners (DME)• GlaxoSmithKline Pazopanib

(ARMD)

Gilbert Abeytagabeyta@e-retina.net 512-454-0138 x201

• Abbott Humira (Uvieitis)• Pfizer NAION

Esra Aytuleaytul@e-retina.net 512-454-0138 x204

• Pfizer B1181002 (Dry ARMD)

Kristen Daviskmcfalls@e-retina.net 512-454-0138 x202

• Alcon RACE (ARMD)• DRCR network trials (DME)

INTRODUCTION

Welcome to the inaugural issue of the quarterly electronic newsletter, Retina Re-search Center News, for clinical news from Retina Research Center and Brian B. Berger, M.D., P.A. This service will provide you with interesting information about new clinical results, clinical trial findings, staff spotlights, diagnostic methods and technologies, and recent publications from Dr. Brian Berger and Dr. Robert Wong. We hope that you enjoy this first edition.

RRC OffeRs fIRsT HeIDlebeRg speCTRAlIs HRA2 + OCT IN AUsTIN

The Retina Research Center is excited to offer the first Heidleberg Spectralis HRA2 + OCT in Austin. This device allows a significant convenience for the patient in that spectral domain optical coherence tomography, autofluorescence, infrared images, red free images, and fluorescein angiography can all be performed by the same unit employing comfortable levels of light exposure for the patient. With the ease of capturing autofluorescence images, we are better able to track the changes associated with dry age-related macular degeneration, including geographic atrophy.

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sUmmeR 2010

Images from the Heidleberg Spectralis (top)

© 2010 Retina Research Center. All rights reserved.

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ClINICAl ResUlTs fROm ReCeNT TRIAls

In the past year, the results of several large prospective randomized-controlled clini-cal trials that we participated in have become available. These results are reshaping our thinking for the treatment of diabetic macular edema, retinal vein occlusion, vitreomacular traction syndrome, and uveitis.

DRCR Protocol I showed that intravitreal Lucentis is an extremely effective treatment with the visual acuity improvement from Lucentis greater than with intravitreal triamcinolone acetonide or laser therapy. Our 11 patients have partici-pated in a minimum of 19 months and a maximum of 39 months for this trial. Their participation will continue for five years.

The Ozurdex steroid implant delivery system from Allergan was also recently approved by the FDA for the treatment of macular edema associated with retinal vein occlusion. We had nine patients participate over this three-year study—Aller-gan 206207-008.

Lux recently completed several uveitis clinical trials that proved Luveniq is an effective treatment for steroid requiring posterior uveitis. Luveniq is a calcineurin inhibitor from the same family as cyclosporine. It seems to be more effective and have fewer side effects than cyclosporine. It is awaiting FDA approval.

Genentech recently received FDA approval for Lucentis for the treatment of retinal vein occlusions. The CRUISE and BRAVO studies showed that intravitreal Lucentis given monthly is an effective treatment for central retinal vein occlusion and branch retinal vein occlusion respectively. We had seven patients participate in these trials.

With your help in entrusting your patients to our care, we have enrolled 269 patients in pivotal trials conducted by the Retina Research Center. We look for-ward to continuing to offer this option to your patients and allowing you and your patients to advance retinal treatments.

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About UsThe Retina Research Center is a dedicated research facility founded by Brian B. Berger, M.D. in 1999. Our medical staff has been performing a variety of clinical trials for over ten years. Since 1999 we have participated in clinical trials focusing on age-related macular degeneration, diabetic retinopathy, retinal vein occlusions, surgical procedures and devices, and uveitis. We also perform retinal exams for local research sites administering systemic medications. Under the direction of Dr. Brian B. Berger, Dr. Robert W. Wong, Dr. Isaac Loose, and Dr. Stephen Whiteside, our site enrolls patients from an extensive patient base referred by many private practices within Austin and the surrounding areas. Our clinical research coordinators and ophthalmic technicians are friendly, knowledgeable, certified, and look forward to helping you and your family receive the newest treatments for retinal diseases.

UpCOmINg pReseNTATIONs & pUblICATIONs

�� Prof. Joaquín Barraque, Presidente de la Sociedad Española de Oftalmología, has invited Dr. Brian Berger to speak on “New Guidelines for the Treatment of Retinal Diseases,” “New Drugs in Development for the Treatment of Retinal Diseases,” and “Instrumentation and Techniques for Minimally Invasive Retinal Surgery” at the Congress of the Spanish Ophthalmology Society, in Madrid, Spain, September 22– 25, 2010.

�� Robert W. Wong, M.D. will present an unusual case at the Medical Retina Case Conference at the upcoming American Society of Retina Specialists meeting held in Vancover, BC, August 28–September 1, 2010.

�� Dr. Wong and co-authors recently published an article entitled “Complications Associated with Clear Corneal Wound During Vitrectomy” in the June 2010 issue of the journal Retina. Robert W. Wong, M.D.

Brian B. Berger, M.D.

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eNROllINg TRIAls

Wet Age-Related macular Degeneration

�� Alcon RACE C-09-067—A Phase II trial evaluating the combination of Lu-centis and AL-78898A to extend the time to retreatment compared to Lucentis monotherapy in patients with wet ARMD.

�� GSK MD1114155—A Phase IIa trial evaluating the systemic safety, tolerability, pharmacokinetics, and exploratory efficacy and phar-macodynamics of 28 days of repeat administration of pazopanib (Votrient) orally in wet ARMD patients with previously untreated, minimally classic or occult subfoveal CNV.

Dry Age-Related macular Degeneration

�� Pfizer B1181002—A Phase I trial evaluating the safety, immuno-genicity, and tolerability of multiple, ascending intravenous (IV) dosages of RN6G (monoclonal antibody binding amyloid beta).

Diabetic macular edema

�� Molecular Partners MP0112-CP02—A Phase I trial evalu-ating the safety and tolerability of single ascending doses of MP0112(DARPins) administered by intravitreal injection in patients with DME.

�� DRCR Network Protocols—The evaluation of the relationship between macular edema and cataract surgery. The evaluation of Lucentis for diabetic vitreous hemorrhage.

Uveitis

�� Abbott M10-877, M10-880, M10-327—A Phase III trial evaluat-ing the efficacy and safety of Adalimumab (Humira) 8omg loading dose followed by 40 mg dose given every other week for the treat-ment of non-infectious active and quiescent posterior and interme-diate uveitis.

�� Lux Biosciences LX211-11—A Phase III trial evaluating the efficacy and safety of LX211(LUVENIQ) in patients with active non-infectious uveitis of the intermediate or posterior segments of the eye.

Other

�� Pfizer NAION—The evaluation of the association of PDE5 inhibition with acute NAION within a pharmacokinetically defined time period following drug ingestion.

Pfizer B1181002

DARPins

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Retina Research Center is a proud sponsor of the AOS summer social for 2010.

Please Visit us at our newly developed Web site www.retinaresearchcenter.com

LUVENIQ