Minocycline to Treat Central Retinal Vein Occlusion

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Retinal Vein Occlusion

In brief

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 facts

Study ID

NCT01468844

Run by

National Eye Institute (NEI)

People needed

6

Starts

2011-12-21

Expected to finish

2015-05-13

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A participant is not eligible if any of the following exclusion criteria are present.
• Participant is in another investigational study and actively receiving investigational product for CRVOs.
• Participant is unable to comply with study procedures or follow-up visits.
• Participant has a known hypersensitivity to sodium fluorescein dye.
• Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
• Participant has a history of chronic renal failure requiring dialysis or kidney transplant.
• Participant has a history of chronic hepatitis or liver failure.
• Participant has an allergy or hypersensitivity to minocycline or any drug in the tetracycline family.
• Participant is currently taking a tetracycline medication.
• Participant is taking any medication that could adversely interact with minocycline such as methoxyflurane.
• Participant has a blood pressure of >180/110 (systolic above 180 OR diastolic above 110).
• -If blood pressure is brought below 180/110 by anti-hypertensive treatment, the participant can become eligible.
• Participant is currently being treated with systemic anti-VEGF agents or systemic steroids.
• Participant had a cerebral vascular event (CVA) or myocardial infarction (MI) within three months prior study entry.
• Participant has a history of thyroid cancer.
• STUDY EYE ELIGIBILITY CRITERIA:
• The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.
• STUDY EYE INCLUSION CRITERIA:
• The study eye has a best-corrected ETDRS visual acuity score between 78 and 34 letters (i.e., between 20/32 and 20/200)
• The study eye shows definite retinal thickening due to a CRVO based on clinical examination involving the center of the macula that is not refractory to further therapy as based on the investigator s clinical judgment. CRVO is defined as an eye that had retinal hemorrhage or other biomicroscopic evidence of RVO (e.g., telangiectatic capillary bed) and a dilated (or previously dilated) venous system in at least three quadrants of the retina drained by the affected vein.
• The study eye has retinal thickness in the central subfield on baseline OCT measurement > 350 microns, as measured by Zeiss Cirrus spectral domain OCT, or an equivalent retinal thickness on a similar OCT machine.
• The study eye has media clarity and pupillary dilation sufficient for adequate fundus photographs. Furthermore, the participant must be able to cooperate during the procedure for accurate fundus photographs.
• STUDY EYE EXCLUSION CRITERIA:
• Macular edema is considered to be due to a cause other than CRVO.
• -An eye should not be considered eligible if:

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Bristol Eye Hospital — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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