A Multicenter, Randomized, Double-Blind, Controlled Clinical Study of Minocycline for the Treatme… (NCT07082855) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Multicenter, Randomized, Double-Blind, Controlled Clinical Study of Minocycline for the Treatment of Retinitis Pigmentosa
China126 participantsStarted 2025-07-15
Plain-language 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.
Who can participate
Age range18 Years – 60 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:
* 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.
What they're measuring
1
The change of ERG
Timeframe: 12 months
Trial details
NCT IDNCT07082855
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University