Evaluation of Intravitreal Aflibercept for the Treatment of Severe Nonproliferative Diabetic Retinopathy: Results From the PANORAMA Randomized Clinical Trial.
Brown DM, Wykoff CC, Boyer D, Heier JS, Clark WL, Emanuelli A, Higgins PM, Singer M, Weinreich DM, Yancopoulos GD, Berliner AJ, Chu K, Reed K, Cheng Y, Vitti R.
Main finding: There were significantly more eyes with moderately severe to severe NPDR treated with aflibercept that showed a 2-step or greater improvement in Diabetic Retinopathy Severity Scale level at 24, 52, and 100 weeks.
There were significantly fewer eyes treated with aflibercept vs sham that developed vision-threatening complications and center-involved DME.
Purpose: To evaluate vascular endothelial growth factor blockade therapy with intravitreal aflibercept injections in eyes with severe NPDR without diabetic macular edema.
Study type: Randomized controlled Trial
Condition: Severe NPDR
Participants: Severe NPDR with no diabetic macular edema
n=402
Intervention:
Group 1: Aflibercept 2mg 3x monthly doses, 1 8-week interval, then every 16 weeks (AFLI 2q16)
Group 2: Aflibercept 2mg 5x monthly doses then every 8 weeks, then PRN from week 56 (AFLI 2q8/PRN)
Group 3: Sham injections (control)
AFLI 2q16
AFLI 2q8/PRN
Control
2-step or greater improvement in DRSS level at 52 weeks
65.2%
79.9%
79.9%
Proportion that developed vision-threatening complications/Ci-DME through week 100
16.3%
18.7%
50.4%
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