Main finding: VEGF Trap-Eye resulted in significant visual gain at 1 year.
Purpose: To compare different doses and dosing regimens of Vascular Endothelial Growth Factor Trap-Eye with laser photocoagulation in eyes with diabetic macular edema
Study type: Randomized controlled trial
Condition: Diabetic Macular Edema
Participants: Type 1 or 2 DM, Ci-DME , VA 20/40-20/320 (6/12-6/96) and central subfield thickness ≥250 μm
n=221
Intervention:
Group 1: Aflibercept (AFLI) 0.5mg every 4 weeks (0.5q4)
Group 2: Aflibercept 2mg every 4 weeks (2q4)
Group 3: Aflibercept 2mg every 8 weeks after 3 initial monthly doses (2q8)
Group 4: Aflibercept 2mg PRN after 3 initial monthly doses (2PRN)
Group 5: Laser (macular)
Outcomes
AFLI 0.5q4
AFLI 2q4
AFLI 2q8
AFLI 2PRN
Laser
Mean BCVA change (letters) at 1 year
+11.0
+13.1
+9.7
+12.0
-1.3
BCVA gain ≥ 15 letters (Proportion of patients)
40.9%
45.5%
23.8%
42.2%
11.4%
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