Retinitis Pigmentosa Clinical Trial
Official title:
The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial
Verified date | April 2023 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the efficacy and safety of oral minocycline (100mg/d), administered for 6 months, for the treatment of patients with retinitis pigments(RP).
Status | Completed |
Enrollment | 35 |
Est. completion date | December 1, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Clinical diagnosis of Retinitis Pigmentosa: nyctalopia, visual field constriction and loss of central vision; degeneration of peripheral rod photoreceptor and retinal pigment epithelium cells. - Age from 18 to 60 years old. - BCVA >20/100(0.2) at least in one eye. - Full-field cone electroretinogram amplitude to 30-Hz flashes >0uV at least in one eye. - Written informed consent is provided. Exclusion Criteria: - Glucocortticoids or tetracycline were used within 3 months. - Vitamin A, DHA and other neurotrophic drugs were used within 3 months. - Other ocular diseases or fundus diseases except cataract: glaucoma, diabetic retinopathy, retinal detachment. - Tetracycline or minocycline allergy or intolerance. - Renal or hepatic insufficiency. - History of thyroid neoplasm. - History of idiopathic intracranial hypertension. - Pregnant or lactating females. |
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of full-field cone electroretinogram amplitude to 30-Hz flashes | increase of full-field cone electroretinogram amplitude to 30-Hz flashes | 12 months, 24 weeks | |
Secondary | change of visual field area | HFA30-2 and HFA60-4 | 12 months, 24 weeks | |
Secondary | Best Corrected Visual Acuity | increase of BCVA | 12 months, 24 weeks | |
Secondary | other ERG indexes | ERG indexes | 12 months, 24 weeks | |
Secondary | color vision | Farnsworth-Munsell 100-hue test (FM-100) | 12 months, 24 weeks | |
Secondary | Contrast sensitivity | Functional Acuity Contrast Test (FACT) | 12 months, 24 weeks | |
Secondary | central foveal thickness | central foveal thickness via OCT | 12 months, 24 weeks |
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