Trial intelligence / Profile preview

Minocycline for Retinitis Pigmentosa

NCT07082855Phase 3

Key facts

Status: Not yet recruiting
Start: Jul 2025
Primary completion: Feb 2028
Countries: 1
Sponsor: Zhongshan Ophthalmic Center
Modality: Small Molecules

Drugs: minocycline
Conditions: retinitis pigmentosa (RP)

Overview

Phase 3, randomised, double-blind trial of minocycline in retinitis pigmentosa (RP) (3 arms), sponsored by Zhongshan Ophthalmic Center. Primary endpoint: Change of Electroretinogram at 12 months. Planned start Jul 2025; status: not yet recruiting.

Design

3 arms

Study design: RandomizedDouble-blind

Minocycline 100mg
Minocycline 100mg daily (100mg AM + Placebo PM)
Minocycline 200mg
Minocycline 200mg daily (100mg BID)
Placebo
Placebo BID

Who it enrols

Patients aged 18-60 with clinically diagnosed retinitis pigmentosa, reduced ERG responses, and constricted visual fields. Must have 30Hz flicker ERG amplitude >= 0 microvolts in at least one eye and BCVA >= 0 in both eyes. Excludes patients with syndromic RP, other ocular diseases, or severe uncontrolled comorbid conditions.

Endpoints

Primary

Change of Electroretinogram12 months

Secondary

Change of Best-Corrected Visual Acuity12 months
Change of Visual Field12 months
Change of color vision12 months
Change of microperimetry12 months
Change of contrast sensitivity12 months
Change of Optical Coherence Tomography12 months
Change of National Eye Institute Visual Function Questionnaire-2512 months
Change of other Electroretinogram amplitude12 months

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