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Minocycline to Treat Branch Retinal Vein Occlusion

NCT01468831 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-01-26

Study results available
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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.

Conditions

  • Retinal Vein Occlusion

Interventions

DRUG

Minocycline

100 mg of minocycline in a pink opaque capsule

OTHER

Placebo

Pill with inactive ingredients in a pink opaque capsule

DRUG

Bevacizumab

1.25 mg bevacizumab injection

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Principal Investigators

  • Catherine A Cukras, M.D. · National Eye Institute (NEI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-28
Primary Completion
2020-02-25
Completion
2021-03-18
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01468831 on ClinicalTrials.gov