Minocycline Treatment for Cystoid Macular Edema

Phase 1

Recruiting

• Conditions: Minocycline; Cystoid Macular Edema
• Interventions: Drug: minocycline

• Registration Number: NCT05474950
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2022-07-23
• Study First Submitted QC: 2022-07-23
• Study First Posted: 2022-07-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
minocycline	minocycline	-

Primary Outcome Measures

Name	Time	Method
Change of cystoid macular edema	At 6 months	Change of CME measured by Optical coherence tomography (OCT)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China