Minocycline Treatment in Retinitis Pigmentosa

Study Overview
=================
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.

Official Title
-----------------
The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial

Conditions
-----------------
Retinitis Pigmentosa, Inherited Retinal Dystrophy, Retina Disorder

Intervention / Treatment
-----------------
* Drug: Minocycline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline<br>Tablets Minocycline 100mg po per day for 12 months | Drug: Minocycline<br>* Tab. Minocycline 100mg po per day for 12 months<br>* Other names: Minocyclin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinitis Pigmentosa, Minocycline, ERG, Inherited Retinal Dystrophy, Retinal Degenerative Disease