MINOCME: Minocycline Treatment for Cystoid Macular Edema

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05474950
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 77
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Minocycline; Cystoid Macular Edema	Drug: minocycline	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of the Treatment of Minocycline for Cystoid Macular Edema
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: minocycline	Drug: minocycline; minocycline capsule (100mg) per day orally

Outcome Measures

Primary Outcome Measures

1. Change of cystoid macular edema [At 6 months]

   Change of CME measured by OCT

Secondary Outcome Measures

1. Change of BCVA [At 6 months]

   Change of BCVA measured by ETDRS

2. Change of macular sensitivity [At 6 months]

   Change of BCVA measured by MAIA

3. Change of retinal vascular leakage [At 6 months]

   Change of retinal vascular leakage measured by FFA or ICGA

4. Change of macular vessel [At 6 months]

   Change of macular vessel measured by OCTA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center	Guangzhou	Guangdong	China	510000

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dan Liang, Dan Liang, PhD, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05474950
• Other Study ID Numbers: MINOCME
• First Posted: Jul 26, 2022
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Edema; Edema; Minocycline

Study Results

No Results Posted as of Jul 26, 2022