Back to resultsMinocycline Treatment for Cystoid Macular Edema (MINOCME)
Primary Purpose
Minocycline, Cystoid Macular Edema
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
minocycline
Sponsored by
About this trial
This is an interventional treatment trial for Minocycline
Eligibility Criteria
Inclusion Criteria:
- Participant diagnosed with CME.
- 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.
- Female that is pregnant, breast-feeding or planning to become pregnant.
- Participant that is currently using other medications.
Sites / Locations
- Zhongshan Ophthalmic CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
minocycline
Arm Description
Outcomes
Primary Outcome Measures
Change of cystoid macular edema
Change of CME measured by Optical coherence tomography (OCT)
Secondary Outcome Measures
Change of best corrected visual acuity (BCVA)
Change of BCVA measured by the Early Treatment Diabetic Retinopathy Study
Change of macular sensitivity
Change of BCVA measured by Macular Integrity Assessment (MAIA)
Change of retinal vascular leakage
Change of retinal vascular leakage measured by Fundus fluorescein angiography (FFA) or indocyanine green angiography (ICGA)
Change of macular vessel
Change of macular vessel measured by optical coherence tomography angiography (OCTA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05474950
Brief Title
Minocycline Treatment for Cystoid Macular Edema
Acronym
MINOCME
Official Title
Efficacy and Safety of the Treatment of Minocycline for Cystoid Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (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
Cystoid macular edema (CME) is one of sight-threatening, immune-related ocular diseases. The efficacy of current treatments for CME (anti-VEGF, glucocorticoids and other agents) are limiting. Minocycline, acting as a broad-spectrum antibiotic, is among tetracycline family and recently, its immunomodulatory and anti-apoptosis function has been replied to several immune diseases and degenerative diseases. This study aims to explore the efficacy and safety of minocycline for CME.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minocycline, Cystoid Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
minocycline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
minocycline
Intervention Description
minocycline capsule (100mg) per day orally
Primary Outcome Measure Information:
Title
Change of cystoid macular edema
Description
Change of CME measured by Optical coherence tomography (OCT)
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Change of best corrected visual acuity (BCVA)
Description
Change of BCVA measured by the Early Treatment Diabetic Retinopathy Study
Time Frame
At 6 months
Title
Change of macular sensitivity
Description
Change of BCVA measured by Macular Integrity Assessment (MAIA)
Time Frame
At 6 months
Title
Change of retinal vascular leakage
Description
Change of retinal vascular leakage measured by Fundus fluorescein angiography (FFA) or indocyanine green angiography (ICGA)
Time Frame
At 6 months
Title
Change of macular vessel
Description
Change of macular vessel measured by optical coherence tomography angiography (OCTA)
Time Frame
At 6 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 with CME.
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.
Female that is pregnant, breast-feeding or planning to become pregnant.
Participant that is currently using other medications.
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
Learn more about this trial
Minocycline Treatment for Cystoid Macular Edema
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