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  • Protocol W: Two-Year Results in Diabetic Retinopathy

    By Jean Shaw
    Selected and reviewed by Neil M. Bressler, MD, and Deputy Editors

    Journal Highlights

    JAMA Ophthalmology, July 2021

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    In Protocol W of the DRCR Retinal Network, Maturi et al. investigated whether treatment with intravitreal aflibercept could prevent vision-threat­ening complications in eyes with mod­erate to severe nonproliferative diabetic retinopathy (NPDR). They found that aflibercept was more effective than sham in reducing the likelihood that a patient would develop PDR or center-involved diabetic macular edema (CI-DME). However, the mean change in visual acuity (VA) from baseline to the two-year mark was similar between the two groups.

    For this study, the researchers enrolled 328 adults (399 eyes) with moderate to severe NPDR and no CI-DME. Participants’ mean age was 57 years, and 57.6% were male. Baseline characteristics were balanced between treatment groups. Participants’ eyes were randomly assigned to either sham injections (n = 199) or 2 mg aflibercept (n = 200). Injections were given at baseline and at months 1, 2, and 4. After that, they were given every four months through year 2. Afliber­cept injections were administered as needed if CI-DME developed or when eyes progressed to PDR.

    At the two-year mark, preventive treatment with aflibercept resulted in a more than threefold reduction in CI-DME with decreased VA and a more than twofold reduction in new-onset PDR. Even so, 16.3% of aflibercept-treated eyes developed PDR or CI-DME with VA loss by two years. Moreover, VA was roughly equivalent between the two groups: The adjusted mean difference in VA between afliber­cept and sham was 0.5 letters.

    Protocol W is ongoing and is sched­uled to be completed in 2022. (Also see related commentary by Rajendra S. Apte, MD, PhD, and Christopher K. Hwang, MD, PhD, in the same issue.)

    The original article can be found here.