About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Allergic to tetracycline antibiotics.
Pregnant or breastfeeding.
Syndromic retinitis pigmentosa.
Currently taking tetracycline antibiotics or any medications that may have adverse interactions with minocycline.
Trial design
Parallel
Treatments tested in this trial
Minocycline 100mg
DrugCapsules Minocycline 100mg po per day and placebo 100mg po per day for 12 months
Minocycline 200mg
DrugCapsules Minocycline 100mg po twice a day for 12 months
Placebo
DrugCapsules placebo 100mg po twice a day for 12 months
Treatment groups
Trial outcomes
Primary outcomes
The change of ERG
The proportion of patients in the group who showed an increase in the amplitude of the light-adapted 30Hz flicker ERG response at 12 months post-treatment compared to baseline.
Secondary outcomes
The change of BCVA
The proportion of patients in this group showing an increase from baseline at month 12 of treatment.
The change of VF
The proportion of patients in this group showing an increase from baseline at month 12 of treatment.
The change of color vision
The proportion of patients in this group showing an increase from baseline at month 12 of treatment.
The change of microperimetry
The proportion of patients in this group showing an increase from baseline at month 12 of treatment.
Sponsors and contacts
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