Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic ERM (Protocol AM)

Overview

About this study

The purpose of this study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Visual acuity 20/25 to 20/40.
  • Epiretinal membrane (ERM) must be thought to be the primary cause of vision loss.
  • ERM meeting the following criteria.
  • Symptoms of visual loss and/or distortion (and 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 optical coherence tomography (OCT).
  • Distortion within the central subfield by 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.

Exclusion Criteria:

  • Secondary ERM due to retinal vascular disease, vitreous hemorrhage, retinal detachment, inflammatory disease, or associations other than vitreous syneresis, retinal break, or posterior vitreous detachment.
  • History of vitreous hemorrhage is permitted provided the vitreous hemorrhage did not cause the ERM in the investigator's opinion.
  • Prior retinal tears treated with laser or cryosurgical retinopexy are permitted provided the laser or cryosurgical retinopexy is completed at least one month prior to randomization.
  • Prior intraocular surgery (except uncomplicated cataract extraction).
  • Cataract extraction within prior 3 months.
  • History of diabetic macular edema (DME), retinal vein occlusion (RVO), or uveitis.
  • Past or current macular hole or degenerative lamellar macular hole.
  • Vitreomacular traction within 1,500 microns of the foveal center.
  • Central serous chorioretinopathy.
  • Nonproliferative diabetic retinopathy or worse (diabetic retinopathy severity > 20).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/1/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Odette Houghton, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

More information

Publications

Publications are currently not available