Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
NCT Number: NCT04068207
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).
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Guangzhou, Guangdong, 510060, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tab. Minocycline 100mg po per day for 12 months
Other names: Minocin, Minocyclinum, Minocyclin
Time frame: 12 months, 24 weeks
increase of full-field cone electroretinogram amplitude to 30-Hz flashes
Time frame: 12 months, 24 weeks
HFA30-2 and HFA60-4
Time frame: 12 months, 24 weeks
increase of BCVA
Time frame: 12 months, 24 weeks
ERG indexes
Time frame: 12 months, 24 weeks
Farnsworth-Munsell 100-hue test (FM-100)
Time frame: 12 months, 24 weeks
Functional Acuity Contrast Test (FACT)
Time frame: 12 months, 24 weeks
central foveal thickness via OCT
Sun Yat-sen University
Other
The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial
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