NCT05474950

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

5.4 years

First QC Date

July 23, 2022

Last Update Submit

April 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of cystoid macular edema

    Change of CME measured by Optical coherence tomography (OCT)

    At 6 months

Secondary Outcomes (4)

  • Change of best corrected visual acuity (BCVA)

    At 6 months

  • Change of macular sensitivity

    At 6 months

  • Change of retinal vascular leakage

    At 6 months

  • Change of macular vessel

    At 6 months

Study Arms (1)

minocycline

EXPERIMENTAL
Drug: minocycline

Interventions

minocycline capsule (100mg) per day orally

minocycline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

  • Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.

MeSH Terms

Conditions

cyclopia sequenceMacular Edema

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dan Liang, PhD

Study Record Dates

First Submitted

July 23, 2022

First Posted

July 26, 2022

Study Start

January 1, 2019

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations