Minocycline for Chronic Autoimmune Uveitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
minocycline
Drugminocycline capsule 100mg per day orally
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: minocyclineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change of macular sensitivity
Change of macular sensitivity measured by MAIA
Time frame
At 6 and 12 months2
Change of BCVA
Change of BCVA measured by ETDRS
Time frame
At 6 and 12 months3
Change of Visual field
Change of Visual field measured by HVF 30-2 visual field testing
Time frame
At 6 and 12 months4
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
Time frame
At 6 and 12 monthsSecondary outcomes
1
Change of macular vessel
Change of macular vessel measured by OCTA
Time frame
At 6 and 12 months2
Change of Contrast Sensitivity
Change of Contrast Sensitivity measured by F.A.C.T
Time frame
At 6 and 12 months3
Change of Color Visual
Change of Color Visual measured by FM100
Time frame
At 6 and 12 months4
Change of QoL questionaire
Change of QoL measured by VFI-25
Time frame
At 6 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov