Expired Study
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Indianapolis, Indiana 46290


Purpose:

Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular AMD despite previous AntiVEGF treatment.


Study summary:

Forty subjects will be randomized to receive intravitreal Sirolimus or standard of care treatment in a 1:1 ratio. Over the course of the six month trial plus a 6 month optional extension, subjects will be evaluated monthly. Treatment with Sirolimus will be given at baseline, month 2 and month 4 with sham injections given at months 1, 3 and 5. For subjects in the extension Sirolimus will also be given at months 6, 8 and 10 with sham at month 7, 9, and 11. Subjects in the standard of care group will receive anti-VEGF injections or sham monthly. Retreatment criteria will be based upon continued subretinal edema, intraretinal edema or active chorioretinal neovascularization (CNV)


Criteria:

Inclusion Criteria: - best corrected visual acuity of 5-65, inclusive, in study eye - presence of choroid neovascularization secondary to AMD - persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the past 5 months Exclusion Criteria: - greater than 100 micron decrease in central subfield thickness on Optical Coherence Topography (OCT) since last standard of care visit - history of major ophthalmic surgery in the study eye in the past 3 months - history of significant ocular disease or condition other than exudative AMD that may confound results


NCT ID:

NCT02357342


Primary Contact:

Principal Investigator
Raj K Maturi, MD
Raj K. Maturi, MD, PC


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46290
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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