Minocycline for Chronic Autoimmune Uveitis
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
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
- 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
Secondary Outcome Measures
- Change of macular vessel [At 6 and 12 months]
Change of macular vessel measured by OCTA
- Change of Contrast Sensitivity [At 6 and 12 months]
Change of Contrast Sensitivity measured by F.A.C.T
- Change of Color Visual [At 6 and 12 months]
Change of Color Visual measured by FM100
- Change of QoL questionaire [At 6 and 12 months]
Change of QoL measured by VFI-25
- 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
Inclusion Criteria:
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Participant diagnosed of autoimmune diseases with visual function damage (decrease of BCVA, loss of retinal structure)
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Participant aged from 18-60 years old.
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Participant that signed the informed consent document and is able to complete the following visits.
Exclusion Criteria:
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Participant is allergy to minocycline or tetracyclines.
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Participant has no contraindications of minocycline or tetracyclines.
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Participant has an abnormal function of liver, heart, kidney and thyroid.
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Participant is using glucocorticoids, immunosuppressants or biologics.
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Female that is pregnant, breast-feeding or planning to become pregnant.
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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.- MINOCU