Minocycline for Chronic Autoimmune Uveitis

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis

Conditions
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Minocycline, Uveitis, Retinal Degeneration

Intervention / Treatment
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* Drug: minocycline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: minocycline capsule
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minocycline<br>minocycline capsule 100mg per day orally | Drug: minocycline<br>* minocycline capsule 100mg per day orally<br>|

What is the study measuring?
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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 |