CompletedPhase 1/2

Study of Oral Minocycline in Treating Bilateral Cystoid Macular Edema Associated With Retinitis Pigmentosa

United States7 participantsStarted 2014-05

Plain-language summary

Background: \- Some people with retinitis pigmentosa (RP) have macular edema (swelling) in the central retina. This can cause decreased central vision. The cause of macular edema is unknown, but may involve inflammation. The drug minocycline might help prevent inflammation and therefore might help treat macular edema and improve central visual function . Objectives: \- To see if minocycline helps people with RP and macular edema. Eligibility: \- People 12 years and older with RP who have macular edema in at least on eye. Design: * Participants will be screened with medical and eye disease history. They will have an eye exam and blood tests. One eye with macular edema will be the study eye. If both eyes are affected, one will be designated the study eye. * Participants will visit the clinic at least 9 times over at least 14 months. The first 3 study visits will be monthly, then every 2 months. * Participants will start taking minocycline after visit 3. They will take 1 pill twice daily for at least 1 year. * Participants will keep a medicine diary and bring it to each visit with their pill bottle and unused pills. At each study visit, participants will have some or all of the following tests: * eye and thyroid exams * blood and pregnancy tests * microperimetry: participants will press a button when they see a light on a computer screen * visual field measurement: participants will look at spots on a white screen to test side vision * electroretinogram: A person will be dark adapted by sitting in the dark for 30 minutes. After the placement of numbing eye drops, special contact lenses will be placed . The participant will watch flashing lights and recordings will be made.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * To be eligible, the following inclusion criteria must be met, where applicable. * Participant must be 12 years of age or older. * Participant (or legal guardian) must understand and sign the protocol's informed consent document. * Participant must have evidence of retinitis pigmentosa (RP) as defined by characteristic electroretinogram (ERG) responses and visual fields. * Participant must be able to swallow pills. * 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 ultraviolet (UV) rays and to wear protective clothing, sunglasses and sunscreen \[minimum sun protection factor (SPF) 15\] if s/he must be out in the sun. * Any female participant of childbearing potential must have a negative pregnancy test at screening and be willing to undergo pregnancy tests throughout the study. * Any female participant of childbearing potential and any male participant 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 at least one week after investigational product (IP) discontinuation. Acceptable methods of contraception include: * hormonal contraception (i.e., birth c…

What they're measuring

Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 6 Months Compared to the Average of the Pre-treatment Values.

Timeframe: Pre-treatment and 6 Months

Trial details

NCT IDNCT02140164

SponsorNational Eye Institute (NEI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2015-11

Results submitted2016-11-17