Rapamycin intravitreal injections discontinued early in phase 2 RCT for geographic atrophy due to safety concerns.
This was a phase 2 RCT planned to enroll 50 people with geographic atrophy from age-related macular degeneration, randomized to receive monthly intravitreal sirolimus (440 μg) injections or sham treatment for up to 24 months. The study was terminated in May 2014 before completion due to safety concerns, with no efficacy results reported.
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: — · Research update
What it does not prove
- Limitations have not yet been verified. Read the primary source.
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
- National Eye Institute (NEI) ↗Clinical trial
Source versions
Assessment history
9/24/2026 · SUPERSEDED: Source updated; assessment withdrawn pending review.
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