Randomized Trial Comparing Immediate Vs. Deferred Surgery for Symptomatic ERM

Launched by JAEB CENTER FOR HEALTH RESEARCH · Dec 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the best timing for surgery in patients with a condition called epiretinal membrane (ERM), which can cause blurry or distorted vision. The trial compares two groups: one group will have surgery right away, while the other group will wait and see if their vision changes before deciding on surgery. Researchers want to find out if waiting to have surgery affects how well patients see in the long run and what factors might influence their recovery. They will also look at how to better measure visual distortion, which is a common symptom of ERM.

To participate in the trial, you need to be at least 45 years old and have a certain level of vision (20/40 or better). You should have symptoms of vision loss due to the ERM, which should not be caused by another eye condition. Participants who join the study can expect to be monitored closely and may undergo tests to evaluate their vision and symptoms. This study is still recruiting participants, and it aims to provide valuable information that could help improve treatment for people with ERM in the future.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Age ≥ 45 years
• • E-ETDRS visual acuity 20/40 or better (≥69 letters)
• • o ERM must be thought to be the primary cause of vision loss
• • ERM meeting the following criteria, according to the investigator
• • ERM is not secondary to another condition
• • Symptoms of visual loss and/or distortion (in the opinion of the investigator, the ERM is contributing to the participant's symptoms); either new or worsening in the past 24 months
• • Epiretinal membrane involving or altering the central 3 mm of the macula on OCT
• • Distortion within the central subfield due to ERM on OCT
• • Immediate vitrectomy not required (investigator and participant are willing to wait at least 4 weeks to see if vision remains stable without having to proceed to vitrectomy)
• • No known medical problems that will be a contraindication to surgery
• Key Exclusion Criteria:
• • History of retinal vascular disease
• • History of vitreous hemorrhage if vitreous hemorrhage is thought to have caused the ERM
• • o History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did not cause the ERM in the investigator's opinion
• • History of inflammatory disease unless mild and completely resolved at least one year prior to randomization
• • History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis (except mild uveitis that resolved \>1 year prior to randomization)
• • Prior intraocular surgery (except uncomplicated cataract extraction)
• • Cataract extraction within prior 3 months
• • Laser or cryosurgical retinopexy within one month of randomization
• • Pneumatic retinopexy within one year of randomization
• • Current untreated retinal tear or detachment
• • o A previously treated retinal tear with up to one disc diameter radius of subretinal fluid is permitted
• • Macular hole
• • Degenerative lamellar macular hole
• • o ERM foveoschisis ("tractional" lamellar hole) is permitted
• • Vitreomacular traction within 1,500 microns of foveal center
• • Central serous chorioretinopathy
• • Nonproliferative diabetic retinopathy or worse (DR severity \>20)