Clinical Trial: Minocycline to Treat Branch Retinal Vein Occlusion

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Branch Retinal Vein Occlusions

Brief 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 must agree to protect themselves from sunlight or artificial ultraviolet rays while in this study.
  • 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 pr

    Detailed Summary:

    Objective:

    Retinal vein occlusions (RVO) are significant sources of vision loss, affecting mostly healthy people over 55 years of age. The common source of vision loss is the macular edema accompanying the retinal injury. Very recently, studies employing monthly anti-vascular endothelial growth factor (VEGF) treatments have demonstrated a benefit to this line of treatment; however, the duration of effectiveness appears to be short lived and the length of time needed for these monthly injections remains unknown. A histologic study of human retinas with RVOs found the presence of activated microglia. Microglia are capable of migrating through the retina to sites of inflammation to associate closely with neurons and the vasculature, and are key cellular players in the mediation of processes of chronic inflammation. For these reasons, microglia represent a promising cellular target for forms of therapy that limit the deleterious inflammatory changes found in vein occlusions. Minocycline, a second-generation tetracycline, has been shown to exhibit anti-inflammatory properties, including microglia inhibition. The objective of this study is to investigate the safety and efficacy of minocycline as a microglia inhibitor in participants with branch retinal vein occlusion (BRVO).

    Study Population:

    A minimum of ten and a maximum of 20 participants who meet the eligibility criteria may be enrolled. Eligibility criteria include: foveal center-involved macular edema secondary to a BRVO, retinal thickness in the central subfield greater than 350 microns as measured by optical coherence tomography (OCT) and visual acuity (VA) between 20/32 and 20/200 in the study eye.

    Design:

    In this pilot, d
    Sponsor: National Eye Institute (NEI)

    Current Primary Outcome: 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: ag 6 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Number of intravitreal bevacizumab injections in the minocycline group vs. placebo. [ Time Frame: 6, 12, 18, 24 months ]
    • Change in retinal thickness as measured by OCT at 6, 12, 18 and 24 months vs. baseline. [ Time Frame: 6, 12, 18, and 24 months ]
    • Change in BCVA at 24 months vs. baseline. [ Time Frame: 6, 12, 18, 24 months ]


    Original Secondary Outcome: Same as current

    Information By: National Institutes of Health Clinical Center (CC)

    Dates:
    Date Received: October 8, 2011
    Date Started: September 19, 2011
    Date Completion: June 1, 2018
    Last Updated: May 20, 2017
    Last Verified: March 13, 2017