Status:
COMPLETED
Sirolimus for Advanced Age-Related Macular Degeneration
Lead Sponsor:
National Eye Institute (NEI)
Conditions:
Age-Related Macular Degeneration
Geographic Atrophy
Eligibility:
All Genders
56+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will determine whether a drug called sirolimus is safe to give to people with geographic atrophy (GA) and if it can help preserve vision in patients. GA is an advanced form of dry age-relat...
Detailed Description
Objective: Age-related macular degeneration (AMD), the leading cause of blindness in people over age 65 in the United States, is a heterogeneous clinical entity in which retinal degeneration occurs pr...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 56 or older
- Must understand and sign the protocol's informed consent document
- Must have at least ½ disc area (approximately 1 mm\^2) of GA compatible with AMD present in each eye
- GA is defined as one or more well-defined and often circular patches of partial or complete depigmentation 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 depigmentation may be classified as early GA. The GA in each eye must be able to be photographed in their entirety, and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements
- Must have at least one large druse (greater than or equal to 125 μm) in each eye
- Must not have any evidence or history of exudative disease related to AMD in either eye as determined by a recent fluorescein angiogram performed within 4 months of study enrollment
- Must have a steady fixation in both eyes in the foveal or parafoveal area and media clear enough for good quality photographs
- Must have visual acuity of 20/400 or better in each eye
- Female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse, or agree to practice two acceptable methods of contraception throughout the course of the study and four months after their last study injection. Acceptable methods of contraception include:
- hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
- intrauterine device,
- barrier methods (diaphragm, condom) with spermicide, or
- surgical sterilization (hysterectomy or tubal ligation).
- Exclusion Criteria
- Actively receiving study therapy in another investigational study
- Unable to comply with study procedures or follow-up visits
- Evidence of an 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)
- Has any of the following: a) a history of macular laser, b) a history of photodynamic therapy (PDT), c) received an intravitreal injection of anti-vascular endothelial growth factor (VEGF) agent for wet/exudative AMD at any point, or d) received an intravitreal injection of any other agent (not an anti-VEGF agent) within four months prior to study enrollment
- Participants currently taking or who have previously taken AREDS vitamin supplementation are not excluded.
- Has had a vitrectomy
- Expected to need ocular surgery during the course of the trial
- Has undergone lens removal in the last three months or yttrium aluminum- garnet (YAG) laser capsulotomy within the last month
- On chemotherapy
- On immunosuppressive medication
- On ocular or systemic medications known to be toxic to the lens, retina or optic nerve
- History of ocular herpes simplex virus (HSV)
- Has 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)
- Has a history of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years
- Has laboratory values outside normal limits and considered clinically significant by the investigator
- Is currently taking one of the following drugs: amprenavir, atazanavir, clarithromycin, darunavir, delavirdine, erythromycin, fluconazole (at doses of 200mg or greater), fluvoxamine, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, quinupristin, ritonavir, saquinavir, telithromycin, troleandomycin, verapamil or voriconazole
- Female participant is pregnant or breast-feeding.
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01445548
Start Date
September 1 2011
End Date
February 1 2014
Last Update
July 7 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892