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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Sirolimus

Intravitreal Sirolimus

Group Type EXPERIMENTAL

Sirolimus

Intervention Type DRUG

intravitreal injection

Standard of Care intravitreal anti-VEGF

anti-VEGF intravitreal injections

Group Type ACTIVE_COMPARATOR

Standard of Care intravitreal injections of anti-VEGF

Intervention Type DRUG

intravitreal injections of anti-VEGF

Interventions

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Sirolimus

intravitreal injection

Intervention Type DRUG

Standard of Care intravitreal injections of anti-VEGF

intravitreal injections of anti-VEGF

Intervention Type DRUG

Other Intervention Names

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DE-109 avastin,bevacizumab, eylea, aflibercept,

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No