Minocycline to Treat Central Retinal Vein Occlusion

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Eye Institute (NEI)
Study ID
NCT01468844
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 pink opaque capsule
  • Placebo — DRUG
    Placebo
  • Bevacizumab — DRUG
    1.25 mg bevacizumab injection

Study Details

Background: \- Central retinal vein occlusion (CRVO) is a blockage of the main vein that carries blood away from the retina in the back of the eye. It can lead 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 CRVO. Objectives: \- To test the safety and effectiveness of minocycline as a treatment for central retinal vein occlusion. Eligibility: \- Individuals at least 18 years of age who have central 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. * Participants 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
Dec 21, 2011
Status verified
Feb 2020
Primary completion
Mar 4, 2015
Completion
May 13, 2015

Study Design

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

Arms

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

Primary Outcome Measure

The Primary Outcome is the Comparison Between the Minocycline and Placebo Groups of the 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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