Protocol: Subclinical Diabetic Macular Edema Study
Status: Closed
Start Date: 11/28/2005
End Date: 04/22/2009
Clinical Trial ID:  
Public Dataset:  Download

 

Subclinical Diabetic Macular Edema Study

Protocol Status: Completed

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A. Study Design

  • Prospective, multi-center observational study

B. Objectives

Primary Objective:

  • To determine the incidence of progression of subclinical diabetic macular edema (DME)
    • Subclinical DME defined as no edema involving the center of the fovea as determined by biomicroscopy but with center point thickness on OCT of at least 225 microns but less than or equal to 299 microns
    • Progression defined as increase in center point thickness of at least 50 microns to > 300 microns

Secondary Objectives:

  • To evaluate factors predictive of the presence of subclinical macular edema
  • To determine indicators of risk for progression of subclinical DME

C. Major Eligibility Criteria

  • Age >=18 years.
  • Study eye with:
    • Best corrected E-ETDRS acuity >= 74 letters (20/32 or better)
    • Macular thickness judged to be normal on exam and no treatment anticipated for edema threatening the macula
    • OCT center point thickness 225-299 microns

D. Duration of follow-up: 2 years, with exams after 1 year and 2 years

E. Main Outcome

  • OCT center point of at least 300 microns and an increase of at least 50 microns from baseline at 1-year or 2-year study visits, or treatment for diabetic macular edema.

F. Sample Size: 220 eyes

G. Schedule of Study Visits and Examination Procedures

 

Study Month

 

0

6*

12

18*

24

E-ETDRS visual acuity a

X

 

X

 

X

Fundus photos

7F

 

3F 

 

3F

OCT of study eye

X

 

X

 

X

Eye Exam

X

 

X

 

X

Blood Pressure

X

 

X

 

X

HbA1c b

X

 

X

 

X

Telephone Call c

 

X

 

X

 

History of Rx for DME d

 

 

X

 

X

 

Testing is on both eyes at the initial visit except for OCT which is obtained only on the study eye unless both eyes appear to be eligible at the initial visit by clinical examination. Testing is only performed on the study eye at follow-up unless otherwise specified below.

a =

at baseline, pre-dilation visual acuity by routine clinic measurement of 20/50. If E-ETDRS by DRCR.net protocol not obtained pre-dilation, post-dilation E-ETDRS protocol visual acuity testing is performed. If E-ETDRS post-dilation is a letter score less than 74, then it must be repeated undilated at a later time and be at least a letter score of 74 to continue in the study. Also includes DRCR.net protocol refraction on both eyes at baseline and on the study eye at 12 and 24 months. Visual acuity will be tested on both eyes at all visits.

b =

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).

c =

telephone call to determine if any treatment for macular edema given in either eye and to reinforce need for follow-up.

d =

determined for both eyes at each visit

Note: If a study eye is going to receive treatment for macular edema, the procedure listed above for the annual visits should be completed

If a study subject receives treatment for edema in between protocol visits without obtaining and OCT, OCT will NOT be obtained at a later visit. Further follow-up in the study will not occur.

* Not associated with a patient visit. 
 


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