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NCT00766649 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral GA Associated With AMD
A Phase 1 study of Age-related Macular Degeneration, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT00766649: Completed Phase 1 study of Age-related Macular Degeneration, sponsored by National Eye Institute (NEI).
NCT00766649 is a Phase 1 study of Age-related Macular Degeneration that has completed, run by National Eye Institute (NEI). The registered enrollment target is 11 participants, below the 1,508-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00766649, a Phase 1 study of Age-related Macular Degeneration, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will determine if a drug called sirolimus is safe to give to people with geographic atrophy GA and if it can help preserve vision in patients. GA is an advanced form of dry age-related macular degeneration (AMD). AMD affects the macula, the central part of the retina needed for sharp, clear vision. There are two types of AMD, wet and dry. In dry AMD, cells in the macula die.GA may at least partly be caused by inflammation. Sirolimus helps prevent inflammation and therefore may help treat GA. People with GA in both eyes with visual acuity between 20/20 and 20/400 in each eye may be eligible for this study. Participants undergo the following tests and procedures: * Sirolimus injections in the study eye at each 3-month clinic visit. The drug is injected under the outer layer of the eye after the patient receives antiseptic and numbing drops. Antibiotic drops are continued for 2 days after the injection. * Eye examinations before the first injection, 1 month after the first injection, during each clinic visit (11 to 15 visits over 2 to 3 years) and 3 months after the final injection. The examination includes testing visual acuity, measuring eye pressure and checking eye movements. To examine the inside of the eye, the pupil is dilated with eye drops. Regular photographs of the inside of the eye and optical coherence tomography photographs, which allow measurement of the thickness of the retina, may be taken during the eye examination. * Autofluorescence imaging. The patient sits in a chair with his or her head placed in a chin rest in front of a camera. A light in the camera is used to scan the eye. * Blood tests. Blood is drawn at the first visit and at up to seven study visits to check blood chemistries, such as liver and kidney function. * Urine pregnancy test for women who are able to become pregnant.
Primary Outcome
One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm\^2 on the retina.
Conditions Studied
Interventions
- DRUG Sirolimus
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2008-10 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
What the finished NCT00766649 record still lists
NCT00766649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,508-participant average among 74 other Age-related Macular Degeneration trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Age-related Macular Degeneration appearing as the primary indexed condition, and to 1 intervention - of which Sirolimus is the first listed.
NCT00766649 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00766649 about?
NCT00766649 is a clinical study titled "Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral GA Associated With AMD". This study will determine if a drug called sirolimus is safe to give to people with geographic atrophy GA and if it can help preserve vision in patients. GA is an advanced form of dry age-related macular degeneration (AMD). AMD affects the macula, the central part of the retina needed for sharp, cle...
What is the current status of trial NCT00766649?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2008-10. Estimated completion is 2012-07.
What conditions does trial NCT00766649 study?
This clinical trial studies the following conditions: Age-related Macular Degeneration.
What interventions are being tested in trial NCT00766649?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT00766649?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00766649 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00766649's enrollment target sits among peer trials
11 71st of 74 higher than 3 of 74 other Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Age-related Macular Degeneration 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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