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Clinical Trials in China / NCT07082855
Starting soon Phase 3

A Multicenter, Randomized, Double-Blind, Controlled Clinical Study of Minocycline for the Treatment of Retinitis Pigmentosa

NCT07082855 · tracked via the Priya Life Science China tracker
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Phase 3
Started
2025-07-15
Last updated
2025-07-24

Condition(s) studied

Retinitis PigmentosaInherited Retinal DystrophyRetina Disorder

Investigational drug(s) / intervention(s)

Minocycline 100mgMinocycline 200mgPlacebo

Minocycline 100mg: Capsules Minocycline 100mg po per day and placebo 100mg po per day for 12 months

Minocycline 200mg: Capsules Minocycline 100mg po twice a day for 12 months

Placebo: Capsules placebo 100mg po twice a day for 12 months

Study summary

This is a multicenter, double-blind, randomized controlled clinical trial to get high - level evidence on minocycline's efficacy and safety(100mg/d, 200mg/d) for Retinitis pigmentosa and to find the optimal treatment dose.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Age should be between 18 and 60 years old. * Clinically diagnosed with retinitis pigmentosa, characterized by reduced electroretinogram (ERG) responses and constricted visual fields. * In at least one eye, the amplitude of the 30Hz flicker ERG under photopic conditions should not be lower than 0 microvolts. * The best-corrected visual acuity (BCVA, ETDRS) in both eyes should not be lower than 0. Exclusion Criteria: * Allergic to tetracycline antibiotics. * Pregnant or breastfeeding. * Syndromic retinitis pigmentosa. * Currently taking tetracycline antibiotics or any medications that may have adverse interactions with minocycline. * Currently participating in or having participated in another investigational study within the past 6 months. * Presence of other ocular diseases, including glaucoma, uveitis, age-related macular degeneration, diabetic retinopathy, etc. * History of ocular surgical intervention. * History of uncontrolled severe comorbid conditions, such as renal disease, liver disease, autoimmune disease, thyroid dysfunction, psychiatric disorders, or idiopathic intracranial hypertension. * Inability of the participant to comply with the study-required procedures, such as epilepsy, inability to fixate, or allergy to fluorescein. Inability to understand the content of the study, sign the informed consent form, or comply with the study procedures or follow-up visits. * Inability to swallow capsules.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

More Zhongshan Ophthalmic Center, Sun Yat-sen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07082855 on ClinicalTrials.gov ↗ ← All trials in China