JCHR

Evaluation of Vitrectomy for Diabetic Macular Edema

Protocol Status: Enrollment Completed

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A. Study Design

• Prospective nonrandomized treatment study

B. Objectives

1.  To provide information on the following outcomes in eyes with DME that undergo vitrectomy: visual acuity, retinal thickening, resolution of traction (if present), surgical complications.

2.  To identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial.

C. Major Eligibility Criteria

• Age >=18 years.
• At least one eye meeting the following criteria:
  • Vitrectomy being performed as treatment of DME.
  • Diabetic macular edema on clinical exam
  • Best corrected visual acuity 20/800 or better (E-ETDRS visual acuity score >= 3 letters)
      » Acuity in primary analysis cohort 20/63 to 20/400-see below

D. Treatment
Vitrectomy will be performed by the investigator’s usual routine.

E. Duration of follow-up: One year.

F. Main Outcomes

• Visual acuity
• Retinal thickening (measured on OCT)
• Surgical complications (including intraoperative and perioperative medical complications)

The 6-month data will be considered primary for efficacy analyses, since additional treatment beyond that time point may complicate interpretation of the results. Longer term follow-up will be necessary for documentation of complications, such as cataracts.

G. Sample Size

Up to 400 patients

• Approximately 100 patients meeting the following criteria: vitreomacular traction on OCT, visual acuity 20/63 to 20/400, retinal thickness >300 microns in the central subfield on OCT, and cataract extraction not performed in conjunction with vitrectomy.
• A maximum of 300 additional patients undergoing vitrectomy for DME but not meeting the above criteria.

H. Schedule of Study Visits and Examination Procedures