Minocycline Treatment in Retinitis Pigmentosa

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

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).

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa; Inherited Retinal Dystrophy; Retina Disorder
• Intervention / Treatment: Drug: Minocycline

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minocycline; Tablets Minocycline 100mg po per day for 12 months	Drug: Minocycline; Tab. Minocycline 100mg po per day for 12 months; Other Names: Minocin; Minocyclin; Minocyclinum

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Dan Liang, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2019
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Retinitis Pigmentosa; Minocycline; Inherited Retinal Dystrophy; ERG; Retinal Degenerative Disease
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Diseases; Retinitis; Retinitis Pigmentosa; Retinal Dystrophies; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: 5010-MINO-RP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No