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Subclinical Diabetic Macular Edema Study
Protocol
Status: Enrollment Completed
"Click here to view protocol"
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
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Study Month
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0
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6*
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12
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18*
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24
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E-ETDRS visual acuity a
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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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3F
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3F
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OCT of study eye
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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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Blood Pressure
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X
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X
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X
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HbA1c b
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X
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X
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X
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Telephone Call c
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X
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X
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History of Rx for DME d
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X
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X
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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.
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a =
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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.
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b =
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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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c =
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telephone
call to determine if any treatment for macular edema given in either eye
and to reinforce need for follow-up.
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d =
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determined
for both eyes at each visit
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Note:
If a study eye is going to receive treatment for macular edema, the
procedure listed above for the annual visits should be completed
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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.
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* Not
associated with a patient visit.
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