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Minocycline for Chronic Autoimmune Uveitis

Primary Purpose

Minocycline, Uveitis, Retinal Degeneration

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
minocycline
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Minocycline

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Ophthalmic CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

minocycline

Arm Description

minocycline capsule 100mg per day orally

Outcomes

Primary Outcome Measures

Change of macular sensitivity
Change of macular sensitivity measured by MAIA
Change of BCVA
Change of BCVA measured by ETDRS
Change of Visual field
Change of Visual field measured by HVF 30-2 visual field testing
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

Secondary Outcome Measures

Change of macular vessel
Change of macular vessel measured by OCTA
Change of Contrast Sensitivity
Change of Contrast Sensitivity measured by F.A.C.T
Change of Color Visual
Change of Color Visual measured by FM100
Change of QoL questionaire
Change of QoL measured by VFI-25
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

Full Information

First Posted
July 24, 2022
Last Updated
April 16, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05474729
Brief Title
Minocycline for Chronic Autoimmune Uveitis
Official Title
The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minocycline, Uveitis, Retinal Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
minocycline capsule
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
minocycline
Arm Type
Experimental
Arm Description
minocycline capsule 100mg per day orally
Intervention Type
Drug
Intervention Name(s)
minocycline
Intervention Description
minocycline capsule 100mg per day orally
Primary Outcome Measure Information:
Title
Change of macular sensitivity
Description
Change of macular sensitivity measured by MAIA
Time Frame
At 6 and 12 months
Title
Change of BCVA
Description
Change of BCVA measured by ETDRS
Time Frame
At 6 and 12 months
Title
Change of Visual field
Description
Change of Visual field measured by HVF 30-2 visual field testing
Time Frame
At 6 and 12 months
Title
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses
Description
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses measured by Electroretinogram (ERG) Testing
Time Frame
At 6 and 12 months
Secondary Outcome Measure Information:
Title
Change of macular vessel
Description
Change of macular vessel measured by OCTA
Time Frame
At 6 and 12 months
Title
Change of Contrast Sensitivity
Description
Change of Contrast Sensitivity measured by F.A.C.T
Time Frame
At 6 and 12 months
Title
Change of Color Visual
Description
Change of Color Visual measured by FM100
Time Frame
At 6 and 12 months
Title
Change of QoL questionaire
Description
Change of QoL measured by VFI-25
Time Frame
At 6 and 12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Liang
Phone
(86)-87330402
Email
liangdan@gzzoc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxi Chen
Phone
(86)-87330402
Email
drchenyuxi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Liang
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Liang
Phone
(86)-87330402
Email
liangdan@gzzoc.com
First Name & Middle Initial & Last Name & Degree
Dan Liang
First Name & Middle Initial & Last Name & Degree
Yuxi Chen

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Minocycline for Chronic Autoimmune Uveitis

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