The Course of Response to Focal Photocoagulation for

Diabetic Macular Edema

Protocol Status: Enrollment 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

  • A minimum of 110 eyes.

E. Main Outcomes: OCT-measured retinal thickness and visual acuity

 

F. Examination Procedures at Each Visit

 

 

0

8w

16w

24w*

32w*

40w*

48w*

Visit Window

 

+1w

+1w

+1w

+1w

+1w

+1w

E-ETDRS best corrected visual acuity a

X

X

X

X

X

X

X

OCT

X

X

X

X

X

X

X

Eye Exam

X

X

X

X

X

X

X

Blood pressure

X

 

 

 

 

 

 

HbA1c b

X

 

 

 

 

 

 

 

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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