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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).
Retinitis Pigmentosa (RP)is a sort of inherited blinding disorders and no effective or safe treatment are widely applied for it. The worldwide prevalence of RP is estimated to be 1/5000. RP is characterized by degeneration of peripheral rod photoreceptor(PR) and associated retinal pigment epithelium(RPE) cells. Nyctalopia and visual field constriction are common symptoms. Cone degeneration and associated loss of central vision are typically followed later.
Minocycline, a secord-generation, semi-synthetic tetracycline antibiotic, is a highly lipophilic molecule and can easily pass through the blood-brain barrier. Several animal experiments and clinical trials have reported that minocycline exert anti-apoptotic, anti-inflammatory and antioxidant effects in treating neurodegenerative diseases.
We propose to test the effect and safety of oral minocycline for retinitis pigmentosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline | Experimental | Tablets Minocycline 100mg po per day for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | Tab. Minocycline 100mg po per day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change of visual field area | HFA30-2 and HFA60-4 | 12 months, 24 weeks |
| Best Corrected Visual Acuity | increase of BCVA | 12 months, 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Liang, MD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39627217 | Derived | Chen Y, Pan Y, Xie Y, Shi Y, Lu Y, Xia Y, Su W, Chen X, Li Z, Wang M, Miao S, Yang Y, Jin C, Luo G, Long S, Xiao H, Huang C, Zhang J, Liang D. Efficacy and safety of minocycline in retinitis pigmentosa: a prospective, open-label, single-arm trial. Signal Transduct Target Ther. 2024 Dec 4;9(1):339. doi: 10.1038/s41392-024-02037-2. |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D012164 | Retinal Diseases |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| other ERG indexes | ERG indexes | 12 months, 24 weeks |
| color vision | Farnsworth-Munsell 100-hue test (FM-100) | 12 months, 24 weeks |
| Contrast sensitivity | Functional Acuity Contrast Test (FACT) | 12 months, 24 weeks |
| central foveal thickness | central foveal thickness via OCT | 12 months, 24 weeks |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |