Minocycline to Treat Branch Retinal Vein Occlusion

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

Conditions studied: Retinal Vein Occlusion

In brief

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 facts

Study ID

NCT01468831

Run by

National Eye Institute (NEI)

People needed

9

Starts

2012-03-28

Expected to finish

2021-03-18

Last updated by the study team

2022-01-26

Who can join

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

You may qualify if…

• To be eligible, the following inclusion criteria must be met, where applicable:
• Participant is 18 years of age or older.
• Participant must understand and sign the protocol's informed consent document.
• Female participants of childbearing potential must not be pregnant or breast-feeding and must be willing to undergo serum (BRC sites only) and urine pregnancy tests throughout the study.
• Female participants of childbearing potential and male participants able to father children must meet the following site-specific criteria:
• For the NEI Site: Female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for one week after study medication discontinuation (based on the half life of minocycline which is 11-22 hours). Acceptable methods of contraception include:
• hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
• intrauterine device,
• barrier methods (diaphragm, condom) with spermicide, or
• surgical sterilization (hysterectomy or tubal ligation).
• Note: Oral birth control pills must be used with caution as minocycline decreases the effectiveness of some oral contraceptives. Participants already taking oral contraceptives may continue to use them, but must agree to use at least one other method of birth control while on study.
• For the BRC Sites: Female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, or be completely abstinent from intercourse. Male participants or male partners (of female participants) who have not had a vasectomy or are not abstinent are required to use a condom with spermicide throughout the course of the study and for one week after study medication discontinuation (based on the half life of minocycline which is 11-22 hours). Female participants of childbearing potential or female partners (of male participants) of childbearing potential must practice one of the below acceptable methods of contraception throughout the course of the study and for one week after study medication discontinuation:
• hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
• intrauterine device,
• barrier methods (e.g., diaphragm) with spermicide, or
• surgical sterilization (hysterectomy or tubal ligation).
• Notes: i) Abstinence is only acceptable when it is the participant's preferred and usual lifestyle choice. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. ii) Oral birth control pills must be used with caution as minocycline decreases the effectiveness of some oral contraceptives. Participants already taking oral contraceptives may continue to use them, but must agree to use at least one other method of birth control while on study. iii)) It should be noted that two forms of contraception (as specified above) will be used by sexually active participants for the duration of the study and for one week after study medication discontinuation.
• Participants must agree to notify the study investigator or coordinator if any of their doctors initiate a new medication during the course of the study.
• Participant must have normal renal function and liver function or have mild abnormalities not above grade 1 as defined by the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
• Participant must agree to minimize exposure to sunlight or artificial UV rays and to wear protective clothing, sunglasses and sunscreen (minimum SPF 15) if s/he must be out in the sun.
• Participant has at least one eye that meets the study eye criteria.

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 BRVO.
• 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 greater than 180/110 (systolic above 180 OR diastolic above 110).
• a. 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 to 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 evidence of definite retinal thickening due to a BRVO 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. BRVO 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 one or two quadrants or less of the retina drained by the affected vein. Hemiretinal vein occlusion (HRVO) is an RVO that involves two altitudinal quadrants. In this study, eyes with a HRVO will be considered a BRVO and are given the same treatment as BRVO eyes.
• 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
• The study eye has macular edema considered to be due to a cause other than BRVO.
• 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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