Inherited Retinal Dystrophy, Retina Disorder, Retinitis Pigmentosa
Conditions
Keywords
Retinitis Pigmentosa, Minocycline, ERG, Inherited Retinal Dystrophy, Retinal Degenerative Disease
Brief summary
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).
Detailed description
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.
Interventions
DRUGMinocycline
Tab. Minocycline 100mg po per day for 12 months
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of full-field cone electroretinogram amplitude to 30-Hz flashes | 12 months， 24 weeks | increase of full-field cone electroretinogram amplitude to 30-Hz flashes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity | 12 months， 24 weeks | increase of BCVA |
| other ERG indexes | 12 months， 24 weeks | ERG indexes |
| change of visual field area | 12 months， 24 weeks | HFA30-2 and HFA60-4 |
| Contrast sensitivity | 12 months， 24 weeks | Functional Acuity Contrast Test (FACT) |
| central foveal thickness | 12 months， 24 weeks | central foveal thickness via OCT |
| color vision | 12 months， 24 weeks | Farnsworth-Munsell 100-hue test (FM-100) |
Countries
China
Outcome results
None listed