Phase 2
N=40
Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD
Age-Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02357342 ↗Enrolled (actual)
40
Serious AEs
5.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography — -30.0; 7.5 microns
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sirolimus (Drug); Standard of Care intravitreal injections of anti-VEGF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Maturi, Raj K., M.D., P.C.
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography |
-30.0; 7.5 | — |
| PRIMARY Visual Acuity |
7; 11 | — |
| SECONDARY Visual Acuity (Best Corrected Visual Acuity) |
9; 9 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02357342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.