NCT04068207

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 27, 2023

Status Verified

April 1, 2023

Enrollment Period

3.4 years

First QC Date

August 23, 2019

Last Update Submit

December 19, 2023

Conditions

Retinitis PigmentosaInherited Retinal DystrophyRetina Disorder

Keywords

Retinitis PigmentosaMinocyclineERGInherited Retinal DystrophyRetinal Degenerative Disease

Outcome Measures

Primary Outcomes (1)

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

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

    12 months， 24 weeks

Secondary Outcomes (6)

  • change of visual field area

    12 months， 24 weeks

  • Best Corrected Visual Acuity

    12 months， 24 weeks

  • other ERG indexes

    12 months， 24 weeks

  • color vision

    12 months， 24 weeks

  • Contrast sensitivity

    12 months， 24 weeks

  • +1 more secondary outcomes

Study Arms (1)

Minocycline

EXPERIMENTAL

Tablets Minocycline 100mg po per day for 12 months

Drug: Minocycline

Interventions

MinocyclineDRUG

Tab. Minocycline 100mg po per day for 12 months

Also known as: Minocin, Minocyclinum, Minocyclin
Minocycline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • 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.

    PMID: 39627217DERIVED

MeSH Terms

Conditions

Retinitis PigmentosaRetinal Diseasescyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Dan Liang, MD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lab of ocular immunology in Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

August 25, 2019

Primary Completion

January 31, 2023

Study Completion

December 1, 2023

Last Updated

December 27, 2023

Record last verified: 2023-04

Locations

CN(1)