Minocycline for Chronic Autoimmune Uveitis

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05474729
Collaborator
(none)
10
1
1
61
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
minocycline capsuleminocycline capsule
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: minocycline

minocycline capsule 100mg per day orally

Drug: minocycline
minocycline capsule 100mg per day orally

Outcome Measures

Primary Outcome Measures

  1. Change of macular sensitivity [At 6 and 12 months]

    Change of macular sensitivity measured by MAIA

  2. Change of BCVA [At 6 and 12 months]

    Change of BCVA measured by ETDRS

  3. Change of Visual field [At 6 and 12 months]

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

  4. Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses [At 6 and 12 months]

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

Secondary Outcome Measures

  1. Change of macular vessel [At 6 and 12 months]

    Change of macular vessel measured by OCTA

  2. Change of Contrast Sensitivity [At 6 and 12 months]

    Change of Contrast Sensitivity measured by F.A.C.T

  3. Change of Color Visual [At 6 and 12 months]

    Change of Color Visual measured by FM100

  4. Change of QoL questionaire [At 6 and 12 months]

    Change of QoL measured by VFI-25

  5. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan Ophthalmic Center Guangzhou Guangdong China 510000

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

  • Principal Investigator: Dan Liang, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dan Liang, Dan Liang, PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05474729
Other Study ID Numbers:
  • MINOCU
First Posted:
Jul 26, 2022
Last Update Posted:
Jul 26, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022