Minocycline to Treat Branch Retinal Vein Occlusion

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Eye Institute (NEI)
Study ID
NCT01468831
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Minocycline — DRUG
    100 mg of minocycline in a pink opaque capsule
  • Placebo — OTHER
    Pill with inactive ingredients in a pink opaque capsule
  • Bevacizumab — DRUG
    1.25 mg bevacizumab injection

Study Details

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.

Key Dates

First listed
Nov 10, 2011
Start date
Mar 28, 2012
Status verified
Oct 2021
Primary completion
Feb 25, 2020
Completion
Mar 18, 2021

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants injected with bevacizumab for three months followed by PRN dosing and placebo twice daily for 24 months
  • Experimental: Minocycline
    Participants injected with bevacizumab for three months followed by PRN dosing and 100mg minocycline twice daily for 24 months

Primary Outcome Measure

Mean Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline. [ Time Frame: Baseline to Month 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

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National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

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