INCLUSION CRITERIA:
- Participant must be 55 years of age or older.
- Participant must understand and sign the protocol's informed consent document.
- Participant must have at least 1/2 disc area (approximately 1 mm(2)) of GA compatible with AMD present in each eye. GA is defined as one or more well-defined, usually more or less circular patches of partial or complete de-pigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial de-pigmentation may still be classified as early GA. The GA in each eye must be able to be photographed in their entirety and not contiguous with or within 1000 mico meter of any areas of peripapillary atrophy (PPA).
- Participant must have large drusen (125 micro meter) in at least one eye.
- Participant must have a steady fixation in both eyes in the foveal or parafoveal area and media clear enough for good quality photographs. This will permit randomization.
- Participant must have visual acuity between 20/20 and 20/400 in each eye.
- Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must be willing to undergo urine pregnancy tests throughout the study.
-Both female participants of childbearing potential and male participants able to father a child must agree to practice adequate birth control throughout the course of the study and for three months after their last sirolimus injection. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner).
EXCLUSION CRITERIA:
- Participant is in another investigational study and actively receiving study therapy.
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.).
- Participant has a history of macular laser, photodynamic therapy (PDT), intravitreal injection of any agent (e.g., anti-VEGF, triamcinolone, etc.) or any previous treatment for AMD other than high-dose vitamin supplementation.
- Participant has had a vitrectomy, penetrating keratoplasty or trabeculectomy.
- Participant is expected to need ocular surgery during the course of the trial.
- Participant has undergone lens removal in the last three months or YAG laser capsulotomy within the last month.
- Participant is on chemotherapy.
- Participant is on immunosuppressive medication.
- Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve.
- Participant with a history of malignancy that would compromise the 2-year study survival.
- Participant with a history of ocular Herpes Simplex Virus.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
- History of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years.
- Laboratory values outside normal limits and considered clinically significant by the investigator.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009