Skip to main content
OpenTrials
Completed

NCT Number: NCT04068207

Minocycline Treatment in Retinitis Pigmentosa

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minocycline

Drug

Tab. Minocycline 100mg po per day for 12 months

Other names: Minocin, Minocyclinum, Minocyclin

Primary outcomes

  1. 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

Secondary outcomes

  1. change of visual field area

    Time frame: 12 months, 24 weeks

    HFA30-2 and HFA60-4

  2. Best Corrected Visual Acuity

    Time frame: 12 months, 24 weeks

    increase of BCVA

  3. other ERG indexes

    Time frame: 12 months, 24 weeks

    ERG indexes

  4. color vision

    Time frame: 12 months, 24 weeks

    Farnsworth-Munsell 100-hue test (FM-100)

  5. Contrast sensitivity

    Time frame: 12 months, 24 weeks

    Functional Acuity Contrast Test (FACT)

  6. central foveal thickness

    Time frame: 12 months, 24 weeks

    central foveal thickness via OCT

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2019
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.