Phase 2 N=7 Treatment

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

Retinitis Pigmentosa

Bottom Line

View on ClinicalTrials.gov: NCT02140164 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: 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. — -16.7 microns

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Minocycline (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: National Eye Institute (NEI)
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	-16.7	—
SECONDARY Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 12 Months Compared to the Average of the Pre-treatment Values	-37.3	—
SECONDARY Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 6 Months as Compared to the Average of Pre-treatment Values	—	—
SECONDARY Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 12 Months as Compared to the Average of Pre-treatment Values	—	—
SECONDARY Change in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values	-1.01	—
SECONDARY Change in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values	-1.02	—
SECONDARY Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 6 Months as Compared to the Average of Pre-treatment Values	-3.62	—
SECONDARY Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 12 Months as Compared to the Average of Pre-treatment Values	1.69	—
SECONDARY Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline	—	—
SECONDARY Number of Ocular Adverse Events	3	—
SECONDARY Number of Non-ocular Adverse Events	12	—
SECONDARY Number of Severe Adverse Events	—	—

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.

Eligibility Criteria

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 control pills, injected hormones, dermal patch or vaginal ring),
intrauterine device,
barrier methods (diaphragm, condom) with spermicide, or
surgical sterilization (hysterectomy or tubal ligation).

EXCLUSION CRITERIA

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

Participant is actively receiving study therapy in another investigational study.
Participant is started on (or changed dosage of) topical or systemic carbonic anhydrase inhibitor (CAI) treatment in the 3 months prior to enrollment.
Participant is actively receiving systemic steroids or has received systemic steroids in the 3 months prior to enrollment.
Any female participant of childbearing potential that is pregnant, breast-feeding or planning to become pregnant during the study.
Participant is expected to be unable to comply with study procedures or follow-up visits.
Participant has evidence of an ocular disease other than RP in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, severe myopia).
Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine).
Participant has a condition that would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control) by interfering with the participant s ability to engage in the required protocol evaluation and testing and/or comply with study visits.
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 a history of thyroid cancer.
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 prior history of idiopathic intracranial hypertension.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02140164). 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.