Minocycline Treatment in Retinitis Pigmentosa

December 19, 2023 updated by: Dan Liang, Sun Yat-sen University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 months， 24 weeks
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
Time Frame: 12 months， 24 weeks
HFA30-2 and HFA60-4
12 months， 24 weeks
Best Corrected Visual Acuity
Time Frame: 12 months， 24 weeks
increase of BCVA
12 months， 24 weeks
other ERG indexes
Time Frame: 12 months， 24 weeks
ERG indexes
12 months， 24 weeks
color vision
Time Frame: 12 months， 24 weeks
Farnsworth-Munsell 100-hue test (FM-100)
12 months， 24 weeks
Contrast sensitivity
Time Frame: 12 months， 24 weeks
Functional Acuity Contrast Test (FACT)
12 months， 24 weeks
central foveal thickness
Time Frame: 12 months， 24 weeks
central foveal thickness via OCT
12 months， 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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