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Protocol Details

A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Branched Retinal Vein Occlusions

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-EI-0263

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Branch Retinal Vein Occlusion;
Minocycline;
Macular Edema

Recruitment Keyword(s)

None;
Retinal Vein Occlusion;
Branch Retinal Vein Occlusion;
BRVO;
Macular Edema

Condition(s)

Retinal Vein Occlusion

Investigational Drug(s)

Minocycline

Investigational Device(s)

None

Intervention(s)

Drug: Minocycline

Supporting Site

National Eye Institute

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 to the National Eye Institute. 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 prevent the growth of new blood vessels in the eye.

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Eligibility

INCLUSION CRITERIA:

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 urine pregnancy tests throughout the study.

-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.

-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 listed in Section 3.2.

ENCLUSION CRITERIA:

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 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).

If blood pressure is brought below 180/110 by anti-hypertensive treatment, the participant can become eligible.

-Participant has a history of treatment with systemic anti-VEGF agents or steroids within three months prior to study entry.

-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:

----The macular edema is considered to be related to cataract extraction, or

----Clinical examination and/or OCT suggest that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema, or

----Clinical examination, medical history and/or fluorescein angiography suggest that diabetic retinopathy is the primary cause of the edema.

----The study eye has a history of a recurrent RVO.

----The study eye has a history of RVO present for > 18 months.

----A brisk afferent pupillary defect (APD) is present in the study eye.

----An ocular condition is present in the study eye such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema

(e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, laser scar at fovea, non-retinal condition).

----An ocular condition (other than RVO) is present that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study

(e.g., uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).

----A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal) is present in the study eye.

----The study eye has had panretinal or sectoral scatter photocoagulation (PRP) within four months prior to study entry.

----The study eye has had pars plana vitrectomy within six months prior to study entry.

----The study eye has undergone major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within three months prior to study entry.

----A yttrium aluminum garnet (YAG) capsulotomy has been performed on the study eye within two months prior to study entry.

----The study eye has had treatment < 3 months prior to study entry of intravitreal or periocular steroid injections.

----The study eye has had treatment < 28 days prior to study entry of intravitreal anti-VEGF agents.

Study Eye Selection Criteria in Cases of Bilater Disease:

If both eyes of a participant meet the criteria, the study eye will be determined at the investigator's discretion.


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Citations:

Mitchell P, Smith W, Chang A. Prevalence and associations of retinal vein occlusion in Australia. The Blue Mountains Eye Study. Arch Ophthalmol. 1996 Oct;114(10):1243-7.

Klein R, Klein BE, Moss SE, Meuer SM. The epidemiology of retinal vein occlusion: the Beaver Dam Eye Study. Trans Am Ophthalmol Soc. 2000;98:133-41; discussion 141-3.

Argon laser photocoagulation for macular edema in branch vein occlusion. The Branch Vein Occlusion Study Group. Am J Ophthalmol. 1984 Sep 15;98(3):271-82.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Catherine A. Cukras, M.D.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 3-2531
10 Center Drive
Bethesda, Maryland 20892
(301) 496-9058
cukrasc@mail.nih.gov

Meg (Margaret) E. Gordon, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 435-1833
meg.gordon@nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01468831

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