Phase 2 N=6 Randomized Double-blind Treatment

Minocycline to Treat Central Retinal Vein Occlusion

Retinal Vein Occlusion

Bottom Line

View on ClinicalTrials.gov: NCT01468844 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Mar 2021

Primary outcome: Primary: 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. — 13.3; -2.0 ETDRS letters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Minocycline (Drug); Placebo (Drug); Bevacizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Eye Institute (NEI)
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	13.3; -2.0	—
SECONDARY Number of Participants Improving ≥ 1 logOCT Scale Step in the Study Eye at 12 Months Compared to Baseline	2; 2	—
SECONDARY Number of Participants Improving ≥ 1 logOCT Scale Step in the Study Eye at 24 Months Compared to Baseline	2; 2	—
SECONDARY Number of Bevacizumab Injections From Baseline to 12 Months	5.5; 10.5	—
SECONDARY Number of Bevacizumab Injections From Baseline to 24 Months	7.8; 16.0	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 3 Months Compared to Baseline	0.8; 3.4	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 6 Months Compared to Baseline	0.3; 1.1	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 12 Months Compared to Baseline	-1.7; 1.3	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 18 Months Compared to Baseline	-0.9; 4.5	—
SECONDARY Changes in Mean Macular Sensitivity in the Study Eye as Measured by Microperimetry at 24 Months Compared to Baseline	-1.5; 3.9	—
SECONDARY Mean Change in the ETDRS BCVA in the Study Eye at 24 Months Compared to Baseline	13; -17.0	—
SECONDARY Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 6 Months Compared to Baseline	-272.7; -312.0	—
SECONDARY Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 12 Months Compared to Baseline	-145.3; -458.5	—
SECONDARY Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 18 Months Compared to Baseline	-52.0; -480.5	—
SECONDARY Changes in Retinal Thickness in the Study Eye as Measured by Optical Coherence Tomography (OCT) at 24 Months Compared to Baseline	-227.0; -346.0	—
SECONDARY Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 12 Months Compared to Baseline	2; 1; 0; 1; 0; 0	—
SECONDARY Changes in Fluid Leakage in the Macula of the Study Eye as Demonstrated by Fluorescein Angiography at 24 Months Compared to Baseline.	2; 1; 0; 0; 0; 0	—

Summary

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.

Eligibility Criteria

INCLUSION CRITERIA:

To be eligible, the following participant-level 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.
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).
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).

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.

*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.

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 this 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 AEs 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 listed in the Study Eye Eligibility Criteria below.

EXCLUSION CRITERIA

A participant is not eligible if any of the following exclusion criteria are present.

Participant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01468844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.