Minocycline Treatment in Retinitis Pigmentosa

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2021

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

  • Drug: Minocycline
    • Tab. Minocycline 100mg po per day for 24 weeks

Arms, Groups and Cohorts

  • Experimental: Minocycline
    • Tablets Minocycline 100mg po per day for 24 weeks

Clinical Trial Outcome Measures

Primary Measures

  • change of full-field cone electroretinogram amplitude to 30-Hz flashes
    • Time Frame: 24 weeks
    • increase of full-field cone electroretinogram amplitude to 30-Hz flashes

Secondary Measures

  • change of visual field area
    • Time Frame: 24 weeks
    • HFA30-2 and HFA60-4
  • Best Corrected Visual Acuity
    • Time Frame: 24 weeks
    • increase of BCVA
  • central foveal thickness
    • Time Frame: 24 weeks
    • increase of central foveal thickness

Participating in This Clinical Trial

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). – Full-field cone electroretinogram amplitude to 30-Hz flashes >0uV. – 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dan Liang, Lab of ocular immunology in Zhongshan Ophthalmic Center – Sun Yat-sen University
  • Overall Official(s)
    • Dan Liang, MD, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Overall Contact(s)
    • Dan Liang, MD, 0086-20-87330402, liangd2@mail.sysu.edu.cn

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