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NCT Number: NCT05474729

Minocycline for Chronic Autoimmune Uveitis

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.

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Key information

Conditions

Minocycline Eye Diseases Eye Diseases, Hereditary Retinal Degeneration Retinal Diseases Uveal Diseases Uveitis cyclopia sequence

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Dan Liang

CONTACT

[email protected]

（86）-87330402

Dan Liang

PRINCIPAL_INVESTIGATOR

Yuxi Chen

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Minocycline

Drug

minocycline capsule 100mg per day orally

Primary outcomes

  1. Change of macular sensitivity

    Time frame: At 6 and 12 months

    Change of macular sensitivity measured by MAIA

  2. Change of BCVA

    Time frame: At 6 and 12 months

    Change of BCVA measured by ETDRS

  3. Change of Visual field

    Time frame: At 6 and 12 months

    Change of Visual field measured by HVF 30-2 visual field testing

  4. Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses

    Time frame: At 6 and 12 months

    Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses measured by Electroretinogram (ERG) Testing

Secondary outcomes

  1. Change of macular vessel

    Time frame: At 6 and 12 months

    Change of macular vessel measured by OCTA

  2. Change of Contrast Sensitivity

    Time frame: At 6 and 12 months

    Change of Contrast Sensitivity measured by F.A.C.T

  3. Change of Color Visual

    Time frame: At 6 and 12 months

    Change of Color Visual measured by FM100

  4. Change of QoL questionaire

    Time frame: At 6 and 12 months

    Change of QoL measured by VFI-25

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Liang

CONTACT

[email protected]

（86）-87330402

Yuxi Chen

CONTACT

[email protected]

（86）-87330402

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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