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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02140164
• Date of registration: 14/05/2014
• Prospective Registration: No
• Primary sponsor: National Eye Institute (NEI)
• Public title: Study of Oral Minocycline in Treating Bilateral Cystoid Macular Edema Associated With Retinitis Pigmentosa
• Scientific title: Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated With Retinitis Pigmentosa
• Date of first enrolment: May 2014
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02140164
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Catherine A Cukras, M.D.
• Affiliation: National Eye Institute (NEI)

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

Intervention(s)

Drug: Minocycline

Primary Outcome(s)

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. [Time Frame: Pre-treatment and 6 Months]

Secondary Outcome(s)

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 [Time Frame: Pre-treatment and 12 Months]

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 [Time Frame: Pre-treatment and 12 Months]

Change in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values [Time Frame: Pre-treatment and 12 Months]

Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 12 Months as Compared to the Average of Pre-treatment Values [Time Frame: Pre-treatment and 12 Months]

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 [Time Frame: Pre-treatment and 6 Months]

Number of Severe Adverse Events [Time Frame: Study Duration, up to 16 Months]

Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 6 Months as Compared to the Average of Pre-treatment Values [Time Frame: Pre-Treatment and 6 Months]

Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline [Time Frame: Baseline and 12 Months]

Number of Non-ocular Adverse Events [Time Frame: Study Duration, up to 16 Months]

Change in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values [Time Frame: Pre-treatment and 6 Months]

Number of Ocular Adverse Events [Time Frame: Study Duration, up to 16 Months]

Secondary ID(s)

140108

14-EI-0108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The EMMES Corporation

Results

• Results available: Yes
• Date Posted: 16/01/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02140164