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Compares treatment options for Epiretinal Membrane
Official title Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM
ClinicalTrials.gov ID: NCT05145491
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Glendale, California, United States
- Huntington Beach, California, United States
- Loma Linda, California, United States
- Mountain View, California, United States
- Oakland, California, United States
- Sacramento, California, United States
- Torrance, California, United States
- Jacksonville, Florida, United States
- Sarasota, Florida, United States
- Wesley Chapel, Florida, United States
- Augusta, Georgia, United States
- Sandy Springs, Georgia, United States
- Chicago, Illinois, United States
- Oak Park, Illinois, United States
- Indianapolis, Indiana, United States
- Overland Park, Kansas, United States
- Prairie Village, Kansas, United States
- West Monroe, Louisiana, United States
- Baltimore, Maryland, United States
+ 25 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Glendale, California, United States; Huntington Beach, California, United States; Loma Linda, California, United States; Mountain View, California, United States; Oakland, California, United States and 39 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.