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Rapamycin
Registry update — unassessed

Multi-Center, Randomized, Single Masked Phase 2 Study of Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration

Trial registry update: TERMINATED. No results reported in the supplied registry record.

RCTN=50Notable significance
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Reporter brief

What this changes

The finding has not established an approved change to our evidence assessment.

Source date: Dec 10, 2015 · Discovered: Sep 19, 2026 · Assessed: — · Historical research backfill

What it does not prove

  • The study provides no evidence of efficacy, as it was halted before completion and no outcome data comparing sirolimus to sham are reported.
  • Safety concerns led to early termination, but the specific adverse events are not detailed in this document.
  • The early stopping means any potential benefit or harm from longer-term treatment remains unknown.

Extracted from supplied source material; model confidence is not a measured probability of correctness.

Study details

Design
Rct
Sample size
50
Duration
24 months
Population
50 persons with central or non-central geographic atrophy (GA) associated with age-related macular degeneration (AMD); GA in treated eye between 0.75 and 8 disk areas (DA)
Primary outcome
Slower worsening of geographic atrophy in sirolimus-treated participants compared to sham-treated participants
Effect size
—
Significance
Not reported
Journal
National Eye Institute (NEI)</journal> </invoke>
Published
Dec 10, 2015

Sources

Primary source

Recorded source passages

Abstract or registry material supplied for assessment; source version 1. This is not a claim of full-text review.

This study will seek to enroll 50 persons who have central or non-central geographic atrophy (GA) associated with age-related macular degeneration (AMD).
Eligible participants will be randomly chosen to receive one of the following treatments in the study eye: 1. A 20 μL (440 μg) intravitreal (IVT) injection of sirolimus, or 2. A sham treatment (subconjunctival injection of lidocaine)
The primary goal is to evaluate whether the persons receiving the sirolimus injections show a slower worsening of geographic atrophy compared to the persons receiving the sham injections. A secondary goal is to evaluate the impact of sirolimus on vision compared to the sham.
As of May 30, 2014, study injections were discontinued due to safety concerns. No further enrollments will occur and follow-up will continue on all active study participants on a quarterly basis.

Source versions

Version 1: Unassessed

Version 1: Superseded

Assessment history

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