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NCT01675947 · ClinicalTrials.gov registry record · Phase 2
Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT01675947: Clinical Trial Phase 2 study, sponsored by National Eye Institute (NEI).
NCT01675947 is a Phase 2 study that was terminated before completion, run by National Eye Institute (NEI). The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01675947, a Phase 2 study, was terminated before completion, sponsored by National Eye Institute (NEI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study will seek to enroll 50 persons who have central or non-central geographic atrophy (GA) associated with age-related macular degeneration (AMD). GA in treated eye must be between 0.75 disk areas (DA) and 8 DA. 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) Participants with two (2) eligible eyes will have one eye randomly assigned to receive intravitreal sirolimus and no sham in the fellow eye. The first injection will begin at Day 0, which may occur on the date of screening/enrollment or up to two weeks following screening/enrollment visit, and every month thereafter. The visit schedule is as follows: 1. A clinical evaluation, including safety measures, will occur monthly. 2. Vision will be measured at the screening/enrollment visit and at 2, 3, 6, 9, 12, 18 and 24 months after the first injection has occurred. 3. Fundus autofluorescence will occur at screening/enrollment and at 2, 6, 12, 18 and 24 months after the first injection has occurred. 4. Fundus color photography and optical coherence tomography will occur at screening/enrollment and at 6, 12, 18 and 24 months after the first injection has occurred. 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. NOTE: 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. That is, on visits coinciding with 3 month intervals from date of enrollment.
Interventions
- DRUG Sirolimus
- DRUG Lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
Why NCT01675947 stopped before completion
NCT01675947 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.
NCT01675947 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01675947 about?
NCT01675947 is a clinical study titled "Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy". This study will seek to enroll 50 persons who have central or non-central geographic atrophy (GA) associated with age-related macular degeneration (AMD). GA in treated eye must be between 0.75 disk areas (DA) and 8 DA. Eligible participants will be randomly chosen to receive one of the following tre...
What is the current status of trial NCT01675947?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2012-02. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01675947?
The interventions under investigation include: Sirolimus (DRUG), Lidocaine (DRUG).
Who is sponsoring clinical trial NCT01675947?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01675947's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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