Reporter brief
Rapamycin intravitreal injections discontinued early in phase 2 RCT for geographic atrophy due to safety concerns.
What happened
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.
Why it matters
Assessment pending; this report does not establish a change in evidence.
What it does NOT prove
- Limitations have not been recorded; consult the primary source.
Study design and sample
Rct; Human.
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)
- Design
- Rct
- Sample
- 50
- Journal
- National Eye Institute (NEI)</journal> </invoke>
- Published
- Dec 10, 2015
Effect size
Not recorded.
Caveats
- Assessment: Superseded.
- Only the source material recorded on this evidence page was assessed.
Conflicts and funding
Not recorded.
Previous evidence
See the Rapamycin timeline and recorded assessment for prior evidence.
Primary source
Cancel Death charts and briefs may be reproduced editorially with attribution to CancelDeath.com. This brief is generated from the primary recorded source facts and assessment. Its review status is shown below; verify quotations against the paper before publication.