Minocycline for Chronic Autoimmune Uveitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: minocycline.
- Who it may be relevant to
- Registry conditions: Minocycline, Uveitis, Retinal Degeneration. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis
Overview
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.
Interventions
- Drug minocycline
minocycline capsule 100mg per day orally
Primary outcome measures
- Change of macular sensitivity [Time frame: At 6 and 12 months]
- Change of BCVA [Time frame: At 6 and 12 months]
- Change of Visual field [Time frame: At 6 and 12 months]
- Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses [Time frame: At 6 and 12 months]
Secondary outcome measures (5)
- Change of macular vessel [Time frame: At 6 and 12 months]
- Change of Contrast Sensitivity [Time frame: At 6 and 12 months]
- Change of Color Visual [Time frame: At 6 and 12 months]
- Change of QoL questionaire [Time frame: 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 [Time frame: At 6 and 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Ophthalmic Center — Guangzhou
Identifiers
NCT: NCT05474729 · MINOCU