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Minocycline Treatment in Retinitis Pigmentosa

Primary Purpose

Retinitis Pigmentosa, Inherited Retinal Dystrophy, Retina Disorder

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Minocycline
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retinitis Pigmentosa, Minocycline, ERG, Inherited Retinal Dystrophy, Retinal Degenerative Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minocycline

Arm Description

Tablets Minocycline 100mg po per day for 24 weeks

Outcomes

Primary Outcome Measures

change of full-field cone electroretinogram amplitude to 30-Hz flashes
increase of full-field cone electroretinogram amplitude to 30-Hz flashes

Secondary Outcome Measures

change of visual field area
HFA30-2 and HFA60-4
Best Corrected Visual Acuity
increase of BCVA
central foveal thickness
increase of central foveal thickness

Full Information

First Posted
August 23, 2019
Last Updated
April 16, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04068207
Brief Title
Minocycline Treatment in Retinitis Pigmentosa
Official Title
The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Inherited Retinal Dystrophy, Retina Disorder
Keywords
Retinitis Pigmentosa, Minocycline, ERG, Inherited Retinal Dystrophy, Retinal Degenerative Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minocycline
Arm Type
Experimental
Arm Description
Tablets Minocycline 100mg po per day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
Minocin, Minocyclinum, Minocyclin
Intervention Description
Tab. Minocycline 100mg po per day for 24 weeks
Primary Outcome Measure Information:
Title
change of full-field cone electroretinogram amplitude to 30-Hz flashes
Description
increase of full-field cone electroretinogram amplitude to 30-Hz flashes
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
change of visual field area
Description
HFA30-2 and HFA60-4
Time Frame
24 weeks
Title
Best Corrected Visual Acuity
Description
increase of BCVA
Time Frame
24 weeks
Title
central foveal thickness
Description
increase of central foveal thickness
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Liang, MD
Phone
0086-20-87330402
Email
liangd2@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Liang, MD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Liang, MD
Phone
0086-20-87330402
Email
liangd2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Dan Liang, MD
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Liang
Phone
0086-20-87330402
Email
liangd2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Dan Liang, MD

12. IPD Sharing Statement

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Minocycline Treatment in Retinitis Pigmentosa

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