NCT07082855

Brief Summary

This is a multicenter, double-blind, randomized controlled clinical trial to get high - level evidence on minocycline's efficacy and safety（100mg/d, 200mg/d) for Retinitis pigmentosa and to find the optimal treatment dose.

Trial Health

63
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Trial Health Score

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

Enrollment
126

participants targeted

Target at P25-P50 for phase_3

Timeline
26mo left

Started Jul 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Jul 2025Jun 2028

First Submitted

Initial submission to the registry

July 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

July 15, 2025

Last Update Submit

July 15, 2025

Conditions

Retinitis PigmentosaInherited Retinal DystrophyRetina Disorder

Keywords

Retinitis PigmentosaMinocyclineERGInherited Retinal Dystrophy

Outcome Measures

Primary Outcomes (1)

  • The change of ERG

    The proportion of patients in the group who showed an increase in the amplitude of the light-adapted 30Hz flicker ERG response at 12 months post-treatment compared to baseline.

    12 months

Secondary Outcomes (8)

  • The change of BCVA

    12 months

  • The change of VF

    12 months

  • The change of color vision

    12 months

  • The change of microperimetry

    12 months

  • The change of contrast sensitivity

    12 months

  • +3 more secondary outcomes

Study Arms (3)

Minocycline 100mg

EXPERIMENTAL

Capsules Minocycline 100mg po once in the morning and placebo 100mg po once in the evening for 12 months

Drug: Minocycline 100mg

Minocycline 200mg

EXPERIMENTAL

Capsules Minocycline 100mg po twice a day for 12 months

Drug: Minocycline 200mg

Placebo

PLACEBO COMPARATOR

Capsules placebo 100mg po twice a day for 12 months

Drug: Placebo

Interventions

Minocycline 100mgDRUG

Capsules Minocycline 100mg po per day and placebo 100mg po per day for 12 months

Also known as: MRP intervention 1
Minocycline 100mg
Minocycline 200mgDRUG

Capsules Minocycline 100mg po twice a day for 12 months

Also known as: MRP intervention 2
Minocycline 200mg
PlaceboDRUG

Capsules placebo 100mg po twice a day for 12 months

Also known as: MRP control
Placebo

Eligibility Criteria

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

You may qualify if:

  • Age should be between 18 and 60 years old.
  • Clinically diagnosed with retinitis pigmentosa, characterized by reduced electroretinogram (ERG) responses and constricted visual fields.
  • In at least one eye, the amplitude of the 30Hz flicker ERG under photopic conditions should not be lower than 0 microvolts.
  • The best-corrected visual acuity (BCVA, ETDRS) in both eyes should not be lower than 0.

You may not qualify if:

  • Allergic to tetracycline antibiotics.
  • Pregnant or breastfeeding.
  • Syndromic retinitis pigmentosa.
  • Currently taking tetracycline antibiotics or any medications that may have adverse interactions with minocycline.
  • Currently participating in or having participated in another investigational study within the past 6 months.
  • Presence of other ocular diseases, including glaucoma, uveitis, age-related macular degeneration, diabetic retinopathy, etc.
  • History of ocular surgical intervention.
  • History of uncontrolled severe comorbid conditions, such as renal disease, liver disease, autoimmune disease, thyroid dysfunction, psychiatric disorders, or idiopathic intracranial hypertension.
  • Inability of the participant to comply with the study-required procedures, such as epilepsy, inability to fixate, or allergy to fluorescein. Inability to understand the content of the study, sign the informed consent form, or comply with the study procedures or follow-up visits.
  • Inability to swallow capsules.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

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

Central Study Contacts

Dan Liang, Professor

CONTACT

0086-020-87330402liangdan@gzzoc.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 24, 2025

Study Start

July 15, 2025

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)