Sirolimus Versus AntiVEGF for Wet AMD
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/14/2017 |
| Start Date: | April 2015 |
| End Date: | January 2017 |
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.
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.
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)
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)
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
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