Minocycline for Chronic Autoimmune Uveitis

The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis

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.

Study Overview

• Status: Recruiting
• Conditions: Retinal Degeneration; Uveitis; Minocycline
• Intervention / Treatment: Drug: minocycline

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: minocycline; minocycline capsule 100mg per day orally	Drug: minocycline; minocycline capsule 100mg per day orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of macular vessel	Change of macular vessel measured by OCTA	At 6 and 12 months
Change of Contrast Sensitivity	Change of Contrast Sensitivity measured by F.A.C.T	At 6 and 12 months
Change of Color Visual	Change of Color Visual measured by FM100	At 6 and 12 months
Change of QoL questionaire	Change of QoL measured by VFI-25	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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Uveal Diseases; Eye Diseases, Hereditary; Uveitis; Retinal Degeneration; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: MINOCU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No