Minocycline for Chronic Autoimmune Uveitis

Uveitis Clinical Trial

Official title:

The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474729
• Other study ID #: MINOCU
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Dan Liang
• Phone: (86)-87330402
• Email: liangdan[@]gzzoc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Minocycline
• Retinal Degeneration
• Uveitis

Intervention

Drug:
• minocycline
minocycline capsule 100mg per day orally

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of macular sensitivity	Change of macular sensitivity measured by MAIA	At 6 and 12 months
Primary	Change of BCVA	Change of BCVA measured by ETDRS	At 6 and 12 months
Primary	Change of Visual field	Change of Visual field measured by HVF 30-2 visual field testing	At 6 and 12 months
Primary	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	Change of macular vessel	Change of macular vessel measured by OCTA	At 6 and 12 months
Secondary	Change of Contrast Sensitivity	Change of Contrast Sensitivity measured by F.A.C.T	At 6 and 12 months
Secondary	Change of Color Visual	Change of Color Visual measured by FM100	At 6 and 12 months
Secondary	Change of QoL questionaire	Change of QoL measured by VFI-25	At 6 and 12 months
Secondary	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