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Minocycline Treatment in Retinitis Pigmentosa

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ClinicalTrials.gov Identifier: NCT04068207
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dan Liang, Sun Yat-sen University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Inherited Retinal Dystrophy Retina Disorder Drug: Minocycline Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial
Estimated Study Start Date : September 23, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Minocycline
Tablets Minocycline 100mg po per day for 24 weeks
 Drug: Minocycline
Tab. Minocycline 100mg po per day for 24 weeks
Other Names:
  • Minocin
  • Minocyclinum
  • Minocyclin


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. change of visual field area [ Time Frame: 24 weeks ]
    HFA30-2 and HFA60-4

  2. Best Corrected Visual Acuity [ Time Frame: 24 weeks ]
    increase of BCVA

  3. central foveal thickness [ Time Frame: 24 weeks ]
    increase of central foveal thickness


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068207


Contacts
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Contact: Dan Liang, MD 0086-20-87330402 liangd2@mail.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Dan Liang, MD    0086-20-87330402    liangd2@mail.sysu.edu.cn   
Principal Investigator: Dan Liang, MD         
Zhongshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Dan Liang    0086-20-87330402    liangd2@mail.sysu.edu.cn   
Principal Investigator: Dan Liang, MD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Dan Liang, MD Zhongshan Ophthalmic Center, Sun Yat-sen University
More Information
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Responsible Party: Dan Liang, Lab of ocular immunology in Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04068207     History of Changes
Other Study ID Numbers: 5010-MINO-RP
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019

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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
Keywords provided by Dan Liang, Sun Yat-sen University:
Retinitis Pigmentosa
Minocycline
ERG
Inherited Retinal Dystrophy
Retinal Degenerative Disease
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
 Retinal Degeneration
Genetic Diseases, Inborn
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents