Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD

Maturi, Raj K., M.D., P.C.

Status and phase: Completed; Phase 2

Conditions: Age-Related Macular Degeneration

Treatments: Drug: Standard of Care intravitreal injections of anti-VEGF; Drug: Sirolimus

Study type: Interventional

Identifiers

NCT02357342

RKM008

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Sirolimus

Experimental group

Description:

Intravitreal Sirolimus

Treatment:

Drug: Sirolimus

Standard of Care intravitreal anti-VEGF

Active Comparator group

Description:

anti-VEGF intravitreal injections

Treatment:

Drug: Standard of Care intravitreal injections of anti-VEGF