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Evaluation of Vitrectomy for Diabetic Macular Edema
Protocol Status: Enrollment Completed
"Click here to view protocol"
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
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Study Month
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0
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3
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6
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12
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E-ETDRS visual acuitya
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X
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X
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X
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X
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Fundus photos
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7F
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7F
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7F
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OCT
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X
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X
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X
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X
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IOP
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X
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X
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X
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X
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Eye Examb
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X
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X
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X
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X
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Blood Pressure
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X
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X
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HbA1cc
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X
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X
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Fluor. Angiod
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X
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Testing is on the study eye only.
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a =
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includes protocol refraction. E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.
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b =
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includes lens assessment using standard photos
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c =
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does not need to be repeated if HbA1c and lab normal values are available from within the prior 3 months (at baseline, can be performed within 3 weeks after enrollment).
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d =
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does not need to be performed if not part of usual care.
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