Overview

This trial is active, not recruiting.

Condition age-related macular degeneration
Treatments sirolimus, standard of care intravitreal injections of anti-vegf
Phase phase 2
Targets mTOR, FKBP-12
Sponsor Maturi, Raj K., M.D., P.C.
Start date April 2015
End date December 2016
Trial size 30 participants
Trial identifier NCT02357342, RKM008

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 Anti-VEGF treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Intravitreal Sirolimus
sirolimus DE-109
intravitreal injection
(Active Comparator)
anti-VEGF intravitreal injections
standard of care intravitreal injections of anti-vegf
intravitreal injections of anti-VEGF

Primary Outcomes

Measure
Change in edema from baseline to month 6 measured by central subfield thickness on Heidelberg optical coherence topography
time frame: 6 months

Secondary Outcomes

Measure
visual acuity (best corrected visual acuity)
time frame: 6 months

Eligibility Criteria

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Maturi, Raj K., M.D., P.C..