September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Long-term diabetic retinopathy and macular edema outcomes with anti-VEGF treatments in randomized controlled clinical studies
Author Affiliations & Notes
  • Marco A Zarbin
    Institute of Ophthalmology & Visual Science, Rutgers-New Jersey Medical School, Newark, New Jersey, United States
  • Ivo Stoilov
    Genentech, Inc., South San Francisco, California, United States
  • Na Lu
    Genentech, Inc., South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Marco Zarbin, Genentech/Roche (C), Healios, KK (C), Makindus (C), Novartis Pharma AG (C), Ophthotech (C); Ivo Stoilov, Genentech, Inc. (E); Na Lu, Genentech, Inc. (E)
  • Footnotes
    Support  Genentech, Inc., South San Francisco, CA, provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation.
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2083. doi:
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    • Get Citation

      Marco A Zarbin, Ivo Stoilov, Na Lu; Long-term diabetic retinopathy and macular edema outcomes with anti-VEGF treatments in randomized controlled clinical studies. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2083.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : To examine the similarities and potential differences in long-term vision outcomes (≥2 years) across trials of ranibizumab (RBZ), aflibercept (AFL), and bevacizumab (BVZ) for the treatment of diabetic retinopathy (DR) and diabetic macular edema (DME).

Methods : Study designs, primary endpoints, inclusion/exclusion criteria, baseline (BL) characteristics, long-term vision and DR outcomes, and injection frequencies were compared for the Diabetic Retinopathy Clinical Research Network Protocol-I, -T, and -S, RISE/RIDE, VIVID/VISTA and BOLT. DR severity was evaluated on fundus photographs (FP) graded on the Early Treatment Diabetic Retinopathy Study DR Severity Scale (DRSS).

Results : BL vision varied across the trials. Protocol-I, -T and S enrolled patients with BCVA up to 20/32 (Snellen equivalent), whereas RIDE/RISE and VIVID/VISTA restricted BL BCVA to 20/40 or worse. At BL, 24−34% of eyes in Protocol-I and RIDE/RISE were graded to have mild/moderate proliferative DR (PDR; DRSS 60−65) vs. only 1−7% in VIVID/VISTA and BOLT. The majority of patients in Protocol S had moderate- and high-risk BL PDR. Mean change in BCVA from BL and percentage of patients with 2-step improvement on the DRSS are shown in Figures 1 and 2, respectively. Only 1-year data were available from Protocol T. In most trials, baseline vision correlated with vision gains suggesting a ceiling effect. Injection frequencies (less than monthly) were comparable for the 3 anti-VEGFs despite different doses and molecular structures.

Conclusions : This cross-trial comparison suggests that intensive early anti-VEGF treatment can resolve DME and significantly improve vision. These outcomes were maintained with less than monthly treatment. In Protocol S, RBZ was effective in the management of moderate- and high-risk PDR. Although findings should be interpreted with caution given the limitations of cross-trial comparisons, there was no additional benefit of aflibercept 2 mg over ranibizumab 0.3 mg with respect to treatment burden or DR improvement.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

 

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