NCT05474729

Brief Summary

Autoimmune uveitis is one kind of non-infectious, sight-threatening, relapsing and severe ocular disease. Approximately 20%-25% autoimmune uveitis patients suffer from the dilemma of blindness for the chronic and persistent inflammatory state in the eyes, which results in continuous destroy in the structure of the eyes and gradually leads to irreversible damage on visual function. However, it shows limiting efficacy of current treatment including glucocorticoids, immunosuppressant and biologics for chronic autoimmune uveitis. Minocycline has been regarded to have anti-apoptosis and immunemodulatory function for decades and it has been illustrated to be beneficial in several neuro-degenerative and neuro-inflammatory diseases. This trial aims to investigate the efficacy and safety of minocycline for chronic autoimmune uveitis with retinal degenerative changes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
8mo left

Started Dec 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress87%
Dec 2021Dec 2026

Study Start

First participant enrolled

December 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

4.1 years

First QC Date

July 24, 2022

Last Update Submit

April 16, 2023

Conditions

MinocyclineUveitisRetinal Degeneration

Outcome Measures

Primary Outcomes (4)

  • Change of macular sensitivity

    Change of macular sensitivity measured by MAIA

    At 6 and 12 months

  • Change of BCVA

    Change of BCVA measured by ETDRS

    At 6 and 12 months

  • Change of Visual field

    Change of Visual field measured by HVF 30-2 visual field testing

    At 6 and 12 months

  • Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses

    Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses measured by Electroretinogram (ERG) Testing

    At 6 and 12 months

Secondary Outcomes (5)

  • Change of macular vessel

    At 6 and 12 months

  • Change of Contrast Sensitivity

    At 6 and 12 months

  • Change of Color Visual

    At 6 and 12 months

  • Change of QoL questionaire

    At 6 and 12 months

  • Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of Ocular and Non-ocular Adverse Events

    At 6 and 12 months

Study Arms (1)

minocycline

EXPERIMENTAL

minocycline capsule 100mg per day orally

Drug: minocycline

Interventions

minocyclineDRUG

minocycline capsule 100mg per day orally

minocycline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant diagnosed of autoimmune diseases with visual function damage (decrease of BCVA, loss of retinal structure)
  • Participant aged from 18-60 years old.
  • Participant that signed the informed consent document and is able to complete the following visits.

You may not qualify if:

  • Participant is allergy to minocycline or tetracyclines.
  • Participant has no contraindications of minocycline or tetracyclines.
  • Participant has an abnormal function of liver, heart, kidney and thyroid.
  • Participant is using glucocorticoids, immunosuppressants or biologics.
  • Female that is pregnant, breast-feeding or planning to become pregnant.
  • Participant that is currently using other medications for other diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

cyclopia sequenceUveitisRetinal Degeneration

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesEye Diseases, HereditaryRetinal Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Dan Liang

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Liang

CONTACT

（86）-87330402liangdan@gzzoc.com

Yuxi Chen

CONTACT

（86）-87330402drchenyuxi@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: minocycline capsule
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dan Liang, PhD

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 26, 2022

Study Start

December 1, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

CN(1)