MedDataX Logo

Minocycline Treatment in Retinitis Pigmentosa

NCT ID: NCT04068207

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-25

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinitis Pigmentosa Inherited Retinal Dystrophy Retina Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Retinitis Pigmentosa Minocycline ERG Inherited Retinal Dystrophy Retinal Degenerative Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Minocycline

Tablets Minocycline 100mg po per day for 12 months

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

Tab. Minocycline 100mg po per day for 12 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Minocycline

Tab. Minocycline 100mg po per day for 12 months

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Minocin Minocyclinum Minocyclin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dan Liang

Lab of ocular immunology in Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dan Liang, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Chen Y, Pan Y, Xie Y, Shi Y, Lu Y, Xia Y, Su W, Chen X, Li Z, Wang M, Miao S, Yang Y, Jin C, Luo G, Long S, Xiao H, Huang C, Zhang J, Liang D. Efficacy and safety of minocycline in retinitis pigmentosa: a prospective, open-label, single-arm trial. Signal Transduct Target Ther. 2024 Dec 4;9(1):339. doi: 10.1038/s41392-024-02037-2.

Reference Type DERIVED
PMID: 39627217 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5010-MINO-RP

Identifier Type: -

Identifier Source: org_study_id