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A Pilot Study of Laser
Photocoagulation for
Diabetic Macular Edema
Protocol
Status: Completed
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A.
Study Design
- Randomized, multi-center
clinical trial.
B. Objectives
- This pilot study will compare
laser treatment as we now use it (called “standard method”)
with a similar laser treatment that is milder in intensity, but more
extensive in number (called “mild macular grid” method).
C.
Major Eligibility Criteria
- Age >=18 years.
- Study eye with best corrected
E-ETDRS acuity >19 letters (20/400 or better).
- Definite retinal thickening
due to diabetic macular edema based on clinical exam at or within 500
microns of the macular center for which the investigator believes laser
photocoagulation is indicated.
- A thickness of 250 microns or
more in the central subfield OR a thickness of 300 microns or more in
any one of the four subfields directly adjacent to the central subfield
on optical coherence tomography (OCT).
D.
Treatment Groups
Randomization to one of two treatment groups:
1. Modified ETDRS laser
photocoagulation treatment.
2. Mild Macular Grid photocoagulation
treatment.
For patients with two study eyes, one eye will randomly be
assigned to receive one treatment technique and the other eye will receive
the other treatment technique.
E. Duration of Follow-Up: Three years.
F. Efficacy Outcome
Change in retinal thickening from baseline to 1 year (measured on OCT)
G. Sample Size: Approximately 200 patients.
H.
Schedule of Study Visits and Examination Procedures
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Follow-up Visits (timed from
randomization, months)
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Phase 1
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Phase 2
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Baseline
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3.5
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8
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12
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24
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36
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ETDRS refraction and visual
acuity OU
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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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Fundus photos OU
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7Fa
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3Fa
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3Fa
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7Fa
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7Fa
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7Fa
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ETDRS fluorescein angiography OU
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X
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X
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OCT OU
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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 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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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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X
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HbA1cc
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X
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X
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X
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X
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BUN, creatinine, microalbumin
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X
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Fasting lipid profiled
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X
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a =
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post-laser
photos (only field 2 stereo) to be done in addition after any laser
treatment.
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b =
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exam performed
according to investigator’s usual routine
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c =
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does
not need to be repeated if HbA1c, BUN, creatnine, microalbumin result and
lab normal values are available from within the prior 3 months (at
baseline, can be performed within 3 weeks after randomization)
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d =
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performed
after overnight fast; does not need to be repeated if LDL and triglyceride
results are available in prior 6 months (at baseline, can be performed
within 3 weeks after randomization)
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