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Effect of intravitreous anti-vascular endothelial growth factor vs sham treatment for prevention of vision-threatening complications of diabetic retinopathy: The Protocol W randomized clinical trial

JAMA Ophthalmology Apr 04, 2021

Maturi RK, Glassman AR, Josic K, et al. - In this randomized clinical trial involving 328 adults (57.6% men [230 of 399 eyes]; mean [SD] age, 56 [11] years) with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema, researchers determined the effectiveness of intravitreous aflibercept injections vs sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR. In this randomized clinical trial, the proportion of eyes with moderate to severe NPDR that developed proliferative diabetic retinopathy (PDR) or vision-reducing center-involved diabetic macular edema (CI-DME) was lower with periodic aflibercept compared with sham treatment. However, over the course of 2 years, preventive treatment did not improve visual acuity when compared to observation plus aflibercept treatment only after the development of PDR or vision-reducing CI-DME. The 4-year results will be critical in determining long-term visual acuity outcomes.

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