• Anti-VEGF Comparison in RCT for CRVO-Related Macular Edema

    By Lynda Seminara
    Selected and Reviewed By: Neil M. Bressler, MD, and Deputy Editors

    Journal Highlights

    JAMA Ophthalmology, November 2019

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    Hykin et al. compared the clinical effectiveness of ranibizumab, afliber­cept, and bevacizumab for managing macular edema due to central retinal vein occlusion (CRVO) in a random­ized clinical trial. They found that, at 100 weeks, aflibercept outcomes were noninferior (not worse) to ranibizumab outcomes; results for the comparison of bevacizumab versus ranibizumab were inconclusive, that is, they could not determine if the outcomes were worse or not worse with bevacizumab. In a post hoc analysis, they also noted the comparison of bevacizumab versus aflibercept were inconclusive.

    The authors’ main objective was to determine whether intravitreal administration of either aflibercept or bevacizumab, in comparison to ranibi­zumab, results in a noninferior mean change in vision at 100 weeks for eyes with CRVO-related macular edema. For this prospective study, they enrolled 463 adults treated at 44 ophthalmol­ogy departments of the U.K. National Health Service. The mean age of the study population was 69.1 years; 57.2% were male.

    All participants had visual impair­ment of less than 12 months’ duration caused by CRVO-related macular edema. Best-corrected visual acuity (BCVA) in the study eye ranged from approximately 20/32 to 20/400. Central subfield thickness according to spec­tral-domain optical coherence tomog­raphy was at least 320 μm in the study eye.

    The patients were assigned ran­domly to receive repeated intravitreal injections of ranibizumab (0.5 mg/0.05 mL), aflibercept (2.0 mg/0.05 mL), or bevacizumab (1.25 mg/0.05 mL) during a 100-week period. The main outcome was the adjusted mean change in BCVA in the study eye at week 100. Noninferiority was concluded if the lower bounds of 95% confidence in­tervals (CI) for both the intent-to-treat and per-protocol analyses were above –5 letters.

    At week 100, the mean (standard deviation) gain in BCVA letter score was 12.5 (21.1) for ranibizumab, 15.1 (18.7) for aflibercept, and 9.8 (21.4) for bevacizumab. Aflibercept was found to be noninferior to ranibizumab (intent-to-treat adjusted mean BCVA differ­ence, 2.23 letters; 95% CI, –2.17 to 6.63 letters; p < .001). Bevacizumab was not found to be noninferior to ranibi­zumab (intent-to-treat adjusted mean BCVA difference, –1.73 letters; 95% CI, –6.12 to 2.67 letters; p = .07). In a post hoc analysis, bevacizumab also was not found to be noninferior to afllibercept (adjusted mean BCVA difference, –3.96 letters; 95% CI, –8.34 to 0.42; p = .32). Results of the per-protocol analysis were similar.

    The mean number of injections was lower for the aflibercept group (10.0) than the ranibizumab group (11.8). There was a mean of 11.5 injections (95% CI, 10.7-12.4) in the bevacizum­ab group.

    The authors cautioned that their re­sults must be interpreted in the context of the eligibility criteria and treatment protocols used in this study.

    The original article can be found here.