Retina Research Foundation

a not-for-profit corporation 501 (c)(3)

Our Mission

The Retina Research Foundation's mission is to find cures for blindness. The purpose of the foundation is to fund research in ophthalmology at a dedicated Facility, promote and support patient ophthalmology advocacy, and support and fund international educational activities and continuing medical education.

Annual Report 2005

From the President

We are pleased to present our first annual report for the year 2005. This First year has been very eventful; we have accomplished our initial fundamental goal of the Foundation: The Retina Research Center. After a long period of meticulous planning, the Research Center opened in November 2005. The center is equipped with two ETDRS vision testing lanes, two investigator examination rooms and a procedure room. A coordinator's area has work space for four study coordinators and extensive secure room for study records. A low temperature for blood products, a controlled temperature alarmed and locked refrigerator for investigational study drugs, a blood processing station and an EKG are all part of it.

The Retina Research Center is being put to good use already. There are six multi-center clinical studies presently being conducted at this facility and two large studies are scheduled for the near future. In addition to sponsored trials, the foundation supported independent research projects which have led to two papers submitted for publication and presentation at national and international meetings.

Our principal goals for 2006 are two:

1. Increase our fund raising efforts to achieve financial independence for the Research Center
2. Encourage utilization of this facility by other Capital District investigators.

Board of Directors: Retina Research Foundation, Inc. (2/06)

Planned Expansion of Research Activities with Additional Funding:

Avastin-Lucentis Study

Wet age related macular degeneration is the leading cause of blindness in the developed world. Until recently all therapies merely delayed or partially diminished the path to blindness. Lucentis (RhuFab) is an experimental medication that represents a break through in the treatment of wet age related macular degeneration. It has been used in extensive clinical trial by the Retina Consultants for the past three years with super results and previously blind patients have recovered reading and driving vision. It is anticipated to obtain FDA approval in 2006 and to cost several thousand dollars per monthly injection. Avastin is a similar medication produced by the same company, Genentech, and FDA approved for the treatment of colon cancer. Avastin was never designed or tested for ocular use, but pilot studies have showed very promising results, similar to Lucentis. Avastin however can be purchased from compounding pharmacies at a cost of 30 dollars per month. There is no industry sponsor for any Avastin trial due to its extremely low cost. Currently insurance companies do not cover Avastin therapy since it is viewed as unproven and experimental, and Lucentis is only available in limited amount in a clinical trail at the Retina Research Center. The cost of one year of Avastin therapy is anticipated at 840.00 dollars compared to Lucentis at possibly 48,000.00 dollars for the drug alone. The RRF has already conducted two studies of Avastin and submitted them for publication. The RRF has developed an assay for Avastin with scientists from the Wadsworth Insitute and plans to develop assays for Lucentis.

The Foundation proposes to:

a. Develop a prospective scientific comparison of the pharmacokinetics of Avastin compared to Lucentis with the Wadsworth Institute researchers. This would allow a scientific rationale for evaluation and administration regimens for the less expensive drug. The NYSDOH has applied for a preliminary patent for the assay method developed by our Wadsworth Institute lab, which is the same lab that developed and holds patents for assays on West Nile virus infections and performs reference laboratory work for vector borne disease such as Lyme disease. This will require an additional research scientist position for full time laboratory work, additional reagents and equipment at an estimated cost of 115,000.00 dollars per year.

b. Develop and conduct clinical trials of Avastin use for wet age related macular degeneration, currently not planned by any research organization due to lack of sponsor support. This would require approval from the FDA since the results of these studies can be used to expand the indications of the drug. The estimated cost of FDA Investigational New Drug (IND) application, development of protocol, Internal Review Board (IRB) application and conduct of study is estimated at 250,000.00 dollars of two years. This would also require a new position as full time research coordinator. This study may help lead to an enormous reduction in health care costs.

c. Engage in an NEI clinical trail of Avastin for Diabetic Retinopathy. Diabetic Retinopathy is the second leading cause of blindness in the US after age related macular degeneration. This project would not require additional funding since it is supported by the NEI.

Prevention study of Dry Age Related Macular Degeneration

The Retina Research Center with be involved in a 4000 patients, five year long NEI study of prevention of age related macular degeneration with the use of lutein, zeaxanthin and omega-3 fatty acids. RRC strives to enroll 150 patients to support the NEI initiative. This effort will require an additional research coordinator position and full time utilization of the RRC facility.

Annual Report 2006

Supplement to 2005 Annual Report

New Multicenter Clinical Trials Starting in 2006:

National Eye Institute Studies:

Pharmaceutical Industry Studies:

Retina Research Sponsored Clinical Trials:

Collaborating Research Projects:

Wadsworth Institute & Albany Medical Center:

Neurological Research Center Inc., Bennington, VT:

Albany Medical Center Neurology Department:

SUNY College of Nanoscale Engineering and Science & RPI:

Presentation at Scientific Meetings:

America Society of Retinal Specialists & European Society of Vitreoretinal Specialists Joint Meeting

Cannes, France September 9-13,2006

Association for Research in Vision and Ophthalmology

Ft. Lauderdale, Fl. July 9, 2006

Publications:

Beer PM, Wong SJ, Hammad AM, Falk NS, Khan S, O'Mally M. Vitreous Levels of Unbound Bevacizumab And Unbound Vascular Endothelial Growth Factors In Two Human Subjects. Retina. October; 26(8)871-876

Beer PM, Falk NS, Khan S, O'Mally M Short Term Experience With 303 Intravitreal Bevacizumab Injections in 181 Consecutive Patients. Ophthalmology in review.

Bakri SJ, Nickel J, Yoganathan P, Beer PM. Photodynamic therapy for choroidal neovascularization associated with submacular hemorrhage in age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2006 Jul-Aug;37(4):278-83

Falk NS, Beer PM, Peters GB 3rd Role of intravitreal triamcinolone acetonide in the treatment of postoperative endophthalmitis. Retina. 2006 May-Jun;26(5)545-8.

Costello P, Bakri SJ, Beer PM, Singh RJ, Falk NS, Peters GB, Melendex JA. Vitreous penetration of topical moxifloxacin and gatifloxacin in humans. Retina 2006 Feb; 26(2):191-5.

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