Sirolimus Versus AntiVEGF for Wet AMD
This trial is active, not recruiting.
|Condition||age-related macular degeneration|
|Treatments||sirolimus, standard of care intravitreal injections of anti-vegf|
|Sponsor||Maturi, Raj K., M.D., P.C.|
|Start date||April 2015|
|End date||December 2016|
|Trial size||30 participants|
|Trial identifier||NCT02357342, RKM008|
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 Anti-VEGF treatment.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
anti-VEGF intravitreal injections
Change in edema from baseline to month 6 measured by central subfield thickness on Heidelberg optical coherence topography
time frame: 6 months
visual acuity (best corrected visual acuity)
time frame: 6 months
Male or female participants at least 18 years old.
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 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
|Official title||Sirolimus Versus AntiVEGF for Wet AMD|
|Principal investigator||Raj K Maturi, MD|
|Description||Thirty 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 extention, 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)|
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