NCT05145491: Protocol AM

Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM

Recruiting now NA Last updated 28 January 2026

What this trial tests

NA trial testing Immediate Vitrectomy in Epiretinal Membrane in 400 participants. Currently enrolling.

Timeline

22 February 2022

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Jaeb Center for Health Research
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	400
Start date	22 February 2022
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	46 locations across United Kingdom, United States

Drugs / interventions tested

• Immediate Vitrectomy
• Deferred Vitrectomy

Conditions studied

• Epiretinal Membrane — all drugs for Epiretinal Membrane →

Sponsor

Jaeb Center for Health Research — full company profile →

Who can join

50 and older, any sex, with Epiretinal Membrane. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia but none have ever been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Timing of Epiretinal Membrane Surgery After Uncomplicated Retinal Detachment Repair.
   Bomdica PR, Shepherd EA, Gupta R, Chaturvedi V. · · 2025 · PMID 40384925 · DOI 10.1177/24741264251337107