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The Course of Response to Focal Photocoagulation for
Diabetic Macular Edema
Protocol Status: Completed
"Click here to view protocol"
A. Study Design
· Prospective, multi-center single-group intervention study
B. Major Eligibility Criteria
· Age >18 years
· Type 1 or type 2 diabetes
· Diabetic macular edema involving the center of the macula (OCT central subfield thickness >250 microns)
· Investigator intends to treat the DME with focal photocoagulation
C. Treatment Group
All study eyes will receive modified ETDRS focal photocoagulation (see chapter 3)
A subject may have only one study eye.
D. Sample Size
E. Main Outcomes: OCT-measured retinal thickness and visual acuity
F. Examination Procedures at Each Visit
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0
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8w
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16w
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24w*
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32w*
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40w*
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48w*
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+1w
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+1w
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+1w
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+1w
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+1w
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+1w
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X
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X
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X
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X
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X
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X
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X
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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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X
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X
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X
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Eye Exam
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X
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X
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X
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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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HbA1c b
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X
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Notes:
* follow up continues after 16 weeks only for eyes not receiving additional treatment (see above)
Testing is only required for the study eye unless otherwise specified below
a = protocol refraction and visual acuity performed on both eyes at baseline, and on study eye only at all other visits. E-ETDRS refers to electronic ETDRS testing using the Electronic Visual Acuity Tester that has been validated against 4-meter chart ETDRS testing.
b = does not need to be repeated if HbA1c available from within the prior 3 months; if not available, can be performed within 3 weeks after enrollment.
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