Minocycline Treatment for Cystoid Macular Edema

Cystoid Macular Edema Clinical Trial

— MINOCME  

Official title:

Efficacy and Safety of the Treatment of Minocycline for Cystoid Macular Edema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474950
• Other study ID #: MINOCME
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystoid Macular Edema
• Edema
• Macular Edema
• Minocycline

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 cystoid macular edema	Change of CME measured by Optical coherence tomography (OCT)	At 6 months
Secondary	Change of best corrected visual acuity (BCVA)	Change of BCVA measured by the Early Treatment Diabetic Retinopathy Study	At 6 months
Secondary	Change of macular sensitivity	Change of BCVA measured by Macular Integrity Assessment (MAIA)	At 6 months
Secondary	Change of retinal vascular leakage	Change of retinal vascular leakage measured by Fundus fluorescein angiography (FFA) or indocyanine green angiography (ICGA)	At 6 months
Secondary	Change of macular vessel	Change of macular vessel measured by optical coherence tomography angiography (OCTA)	At 6 months