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Recruiting Phase 1/2

Minocycline for Chronic Autoimmune Uveitis

NCT05474729 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2021-12-01
Last updated
2023-04-18

Condition(s) studied

MinocyclineUveitisRetinal Degeneration

Investigational drug(s) / intervention(s)

minocycline →

minocycline: minocycline capsule 100mg per day orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
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.

Primary outcome measure(s)

  • Change of macular sensitivity — At 6 and 12 months
    Change of macular sensitivity measured by MAIA
  • Change of BCVA — At 6 and 12 months
    Change of BCVA measured by ETDRS
  • Change of Visual field — At 6 and 12 months
    Change of Visual field measured by HVF 30-2 visual field testing
  • 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

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Ophthalmic Center Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05474729 on ClinicalTrials.gov ↗ ← All trials in China