Retina Research Foundation

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

The Foundation is seeking to raise funds for the purchase of two research instruments required for the conduct of the SALVAGE trial. The Salvage trial will attempt to determine if the current therapy for wet macular degeneration (Lucentis) would benefit patients who have advanced disease with macular scarring and who do not currently receive treatment. These patients have been excluded from all previous clinical trials. These are the most desperate patients since they have the most profound loss of vision and are in the greatest need of help.

Lucentis therapy is both invasive and demanding for the patient and also very expensive for society. We will attempt to study the visual function and daily living (quality of life) of patients in the trial. We will use objective means to test visual function. The two research instruments, the MP1 Microperimeter and the Multifocal ERG are required for this purpose.

SALVAGE (Scotoma reduction And Limited Visual Acuity in aGE related macular degeneration patients treated with intravitreal Lucentis)

Description of study rationale and population in need:

Wet Age Related Macular Degeneration (ARMD) is the major cause of blindness in the US and the developed world. by 2020 an estimated 7.5 million Americans will have lost vision secondary to AMD. A new therapy, intraocular injections of Lucentis, has been proven to be effective in the treatment of new cases of we ARMD. The cost of this therapy will be very high, 10,000 to 30,000 dollars per year per eye. Consequently the treatment will be restricted to new cases that have the best chance to benefit from this new medicine.

This leaves a large population of legally blind patients who have had wet ARMD for months or years and who are currently not treated sine there is no proof that this intensive and expensive therapy is beneficial for them. We have proposed a limited clinical trial to study the effects of this therapy on a small number of these otherwise abandoned patients. The study protocol was proposed to and approved by GEnentech, manufacturer of Lucentis. The study will be performed in accordance with and under the supervision of the FDA. The study sponsor will provide free medicine for the study subjects and will fund the costs of clinical procedures required by the study protocol. The sponsor will no provide two critical pieces of testing equipment required for the performance of the study.

Description of visual function measurement research instruments:

MPI Microperimeter:

	This is an instrument designed to map the size and depth of the blind spot area in the center of the retina in patients with macular degeneration. This instrument is fundamental to measuring any treatment benefit in these study patients. This is a research tool not used in our clinical practice. It is manufactured by Nidek at a cost of 51,000 dollars.

Multi-Focal ERG:

This instrument is able to measure electronic output from the small areas in the central retina and quantify improvement in regional retinal function. This instrument is also fundamental to measuring a treatment benefit in these study patients and is purchased specifically for these studies. It is sold by LKC at a cost of 30,000 dollars.

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