Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema

NCT06232616 | Enrolling By Invitation

• 1 other identifier: YFZXYDK202401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. The main questions it aims to answer are:

• mean changes in best corrected visual acuity and central macular thickness from baseline to post-operative 24 weeks
• mean change in proportion of cystoid macular oedema area from baseline to post-operative 24 weeks
• intraocular pressure throughout postoperative 24 weeks
• concentrations of inflammatory factors in vitreous samples Participants will undergo a standard three-port 25-gauge pars plana vitrectomy and epiretinal membrane peeling combined with phacoemulsification, aspiration, and intraocular lens implantation. The dexamethasone implant will be injected into the vitreous cavity at the end of the operation.

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

• improvement of visual acuity

  mean change in best corrected visual acuity

  from baseline to postoperative 24 weeks

Study Arms (1)

Single arm

OTHER

In this single-arm designed study, participants with idiopathic epiretinal membranes with macular oedema were assigned a vitrectomy with an intravitreal dexamethasone implant.

Procedure: vitrectomy combined with intravitreal dexamethasone implant

Interventions

vitrectomy combined with intravitreal dexamethasone implant PROCEDURE

The dexamethasone implant will be injected into the vitreous cavity at the end of the surgery.

Single arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic patients aged 40 years or above with idiopathic stage 3-4 epiretinal membrane defined on the basis of spectral-domain optical coherence tomography classification;
• central retinal thickness \>300 µm;
• cystoid oedema within a 1 mm diameter range with the macular fovea as the center;
• ocular axial length less than 25.00 mm.

You may not qualify if:

• concomitant or previous macular diseases that may hinder visual improvement other than epiretinal membrane (e.g., age-associated macular degeneration, retinal vein occlusion, or diabetic macular oedema);
• previous vitreoretinal surgery or intravitreal injection history;
• history of glaucoma or optic neuropathy of any kind;
• patients with uncontrolled systemic diseases or infectious diseases;
• patients who took medicines that may have ocular side effects, such as glucocorticoid or hydroxychloroquine.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Tao Sun, Ph.D.

  Shanghai Eye Diseases Prevention & Treatment Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 31, 2024
• Study Start: March 11, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the results are published in the journal.
• Access Criteria: E-mail contact

Locations

CN (1)