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NCT01468831 · ClinicalTrials.gov registry record · Phase 1
Minocycline to Treat Branch Retinal Vein Occlusion
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01468831: Completed Phase 1 study, sponsored by National Eye Institute (NEI).
NCT01468831 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468831, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Background: \- Branch retinal vein occlusion (BRVO) is a blockage of the small veins that carry blood away from the retina in the back of the eye. It often leads to macular edema, a swelling of the retina that is a common source of vision loss. Studies suggest that inflammation might be a cause. Minocycline is a drug that might help prevent cells involved in inflammation from becoming activated. It is approved for use as an antibiotic, but it has not yet been tested to see if it can treat BRVO. Objectives: \- To test the safety and effectiveness of minocycline as a treatment for branch retinal vein occlusion. Eligibility: \- Individuals at least 18 years of age who have branch retinal vein occlusion in at least one eye, with vision between 20/32 and 20/200. Design: * This study lasts 2 years, with at least 25 visits. * Participants will be screened with a physical exam and medical history. They will also have blood tests and an eye exam. One eye will be selected as the study eye to receive the medicine. * Those in the study will take minocycline or a placebo pill twice a day, about 12 hours apart, for 2 years. * Participants will have monthly visits for blood tests and full eye exams to study the effect of the treatment. Other exams may include thyroid tests and eye imaging studies. Those in the study may also receive injections of a drug to prevent the growth of new blood vessels in the eye.
Primary Outcome
The primary outcome measure is the mean difference between the minocycline and placebo groups in the change in best-corrected visual acuity (BCVA), as measured in ETDRS letters, in the study eye at 12 months compared to baseline. Values presented represent mean and standard deviation of change from baseline at 12 months.
Interventions
- DRUG Bevacizumab
- OTHER Placebo
- DRUG Minocycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-03-28 |
| Est. Completion | 2021-03-18 |
| Phase | Phase 1 |
What the finished NCT01468831 record still lists
NCT01468831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01468831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01468831 about?
NCT01468831 is a clinical study titled "Minocycline to Treat Branch Retinal Vein Occlusion". Background: \- Branch retinal vein occlusion (BRVO) is a blockage of the small veins that carry blood away from the retina in the back of the eye. It often leads to macular edema, a swelling of the retina that is a common source of vision loss. Studies suggest that inflammation might be a cause. Mi...
What is the current status of trial NCT01468831?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2012-03-28. Estimated completion is 2021-03-18.
What interventions are being tested in trial NCT01468831?
The interventions under investigation include: Bevacizumab (DRUG), Placebo (OTHER), Minocycline (DRUG).
Who is sponsoring clinical trial NCT01468831?
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 NCT01468831's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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