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NCT02564978 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT02564978: Completed Phase 2 study, sponsored by National Eye Institute (NEI).
NCT02564978 is a Phase 2 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02564978, a Phase 2 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
Background: Age-related macular degeneration (AMD) is the main reason older people lose their vision. It affects the macula, the center of the retina needed for sharp, clear vision. Researchers want to see if an antibiotic can help people with an advanced form of AMD, Geographic Atrophy (GA). Objective: To see if minocycline is safe for people with GA and if it helps preserve their vision. Eligibility: People age 55 and older who have GA in at least one eye. Design: Participants will be screened with physical exam, medical history, blood tests, and eye exam. Participants will take minocycline. They will take 1 pill twice a day for at least 3 years. Participants will have a minimum of 11 study visits. (But they are not every 3 months.). At each visit, participants will have a medical history. They may have: Blood tests. Eye exam. Vision, eye pressure, and eye movements will be checked. The pupils may be dilated. The inside of the eyes may be photographed. Their thyroid gland felt while they swallow. Microperimetry. They will sit in front of a computer and press a button when they see a light on the screen. Fluorescein angiography. An intravenous line (IV) will be placed in an arm vein. A dye called fluorescein will be placed in the IV and travel through the veins to the blood vessels in the eyes. A camera will take pictures of the dye as it flows through the eye blood vessels.
Primary Outcome
The difference in the square-root transformed GA area expansion rates in the study eye based on fundus autofluorescence (FAF) between the treatment phase (Month 9 to Month 33) and the run-in phase (baseline to Month 9) was compared using a linear spline regression model with a fixed knot at Month 9, at a Type I error rate of 2.5%.
Interventions
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-12-14 |
| Est. Completion | 2023-03-08 |
| Phase | Phase 2 |
What the finished NCT02564978 record still lists
NCT02564978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Minocycline is the first listed.
NCT02564978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02564978 about?
NCT02564978 is a clinical study titled "Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With Age-Related Macular Degeneration". Background: Age-related macular degeneration (AMD) is the main reason older people lose their vision. It affects the macula, the center of the retina needed for sharp, clear vision. Researchers want to see if an antibiotic can help people with an advanced form of AMD, Geographic Atrophy (GA). Obje...
What is the current status of trial NCT02564978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2016-12-14. Estimated completion is 2023-03-08.
What interventions are being tested in trial NCT02564978?
The interventions under investigation include: Minocycline (DRUG).
Who is sponsoring clinical trial NCT02564978?
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 NCT02564978's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 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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