Clinical trial NCT05474729: Minocycline for Chronic Autoimmune Uveitis
Official title: The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Minocycline
Uveitis
Retinal Degeneration
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: minocycline capsule
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of macular sensitivity
timeFrame: At 6 and 12 months
measure: Change of BCVA
timeFrame: At 6 and 12 months
measure: Change of Visual field
timeFrame: At 6 and 12 months
measure: Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses
timeFrame: At 6 and 12 months
Secondary outcomes:
measure: Change of macular vessel
timeFrame: At 6 and 12 months
measure: Change of Contrast Sensitivity
timeFrame: At 6 and 12 months
measure: Change of Color Visual
timeFrame: At 6 and 12 months
measure: Change of QoL questionaire
timeFrame: At 6 and 12 months
measure: 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
timeFrame: At 6 and 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Dan Liang
role: PRINCIPAL_INVESTIGATOR
References: