Retinitis Pigmentosa
Conditions
Interventions
Intervention group 2:Oral administration of minocycline capsules at a dose of 200mg per day, for a continuous period of 12 months.
Intervention group 1:Oral administration of minocycline capsules at a dose of 100mg per day, for a continuous period of 12 months.
Control Group:Placebo tablets that are identical in appearance to the clinical study medication taken orally for 12 consecutive months.
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age should be between 18 and 65 years old; 2. Clinically diagnosed with retinitis pigmentosa, with a 30Hz flash ERG amplitude of 0 microvolts (µV) under photopic conditions in both eyes; 3. In the micro-perimetry test: at least one eye's mean visual sensitivity should be above 0 decibels (dB), and the 95.4% fixation two-dimensional contour ellipse area (BCEA95) should be less than 30deg^2, with both false positive and false negative rates being less than 30%; 4. Cataracts in both eyes should be <= grade 2 (LOCS III grading); 5. Understand the trial content, sign the informed consent form, and comply with research procedures or follow-up visits; 6. Must be able to swallow medications.
Exclusion criteria
Exclusion criteria: 1. Syndrome-type retinitis pigmentosa; 2. Allergy to tetracycline antibiotics; 3. Pregnant or breastfeeding women; 4. Currently taking tetracycline antibiotics or any medications that may have adverse interactions with minocycline; 5. Currently receiving investigational treatment in another study or within 6 months; 6. Other eye diseases, including glaucoma, uveitis, age-related macular degeneration, diabetic retinopathy, etc.; 7. History of eye surgery due to retinitis pigmentosa; 8. History of uncontrolled severe cardiovascular disease, lung disease, kidney disease, liver disease, autoimmune diseases, thyroid dysfunction, mental illness, or intracranial diseases (including idiopathic intracranial hypertension); 9. Unable to complete relevant examinations required by the study, such as seizures, inability to focus, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The non-declining rate of mean sensitivity measured by microperimeter; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE and SAE;Other microperimetry parameters, best-corrected visual acuity, contrast sensitivity, mfERG amplitude, visual-field MD, color-vision score, EZ-band width on OCT, and NEI-VFQ-25 questionnaire score; | — |
Countries
China
Contacts
Public ContactDan Liang
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed