Retinitis Pigmentosa
Conditions
Interventions
Control Group:Placebo capsules that are identical in appearance to the clinical study medication, taken orally for 12 consecutive months.
Test Group 1:Oral administration of minocycline capsules at a dose of 100mg per day, for a continuous period of 12 months.
Test Group 2:Oral administration of minocycline capsules at a dose of 200mg per day, for a continuous period of 12 months.
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age should be between 18 and 60 years old. 2.Clinically diagnosed with retinitis pigmentosa, characterized by reduced electroretinogram (ERG) responses and constricted visual fields. 3.In at least one eye, the amplitude of the 30Hz flicker ERG under photopic conditions should not be lower than 0 microvolts (µV). 4.The best-corrected visual acuity (BCVA, ETDRS) in both eyes should not be lower than 0. 5.The participant should understand the content of the study, sign the informed consent form, and comply with the study procedures or follow-up visits. 6.Able to swallow tablets.
Exclusion criteria
Exclusion criteria: 1. Syndromic retinitis pigmentosa. 2. Allergy to tetracyclines. 3. Pregnant or lactating women. 4. Are taking tetracyclines and any medications that may have adverse interactions with minocycline. 5. Is receiving or within 6 months of study treatment in another investigational study. 6. Have other eye diseases, including glaucoma, uveitis, age-related macular degeneration, diabetic retinopathy, etc. 7. Have undergone eye surgery for retinitis pigmentosa. 8. Has a history of uncontrolled severe cardiovascular disease, pulmonary disease, renal disease, liver disease, autoimmune disease, thyroid dysfunction, psychiatric disease, or idiopathic intracranial hypertension. 9. Participants are unable to cooperate with the completion of relevant examinations specified by the study, such as: epilepsy, inability to fixate, allergy to fluorescein, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of visual function improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of improvement in BCVA, VF MD, color vision score, retinal sensitivity in microperimetry, OCT EZ band width, and NEI-VFQ-25 score.;The proportion of other ERG amplitude indicators showing improvement; | — |
Countries
China
Contacts
Public ContactDan Liang
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed