Investigative Ophthalmology & Visual Science Cover Image for Volume 61, Issue 7
June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Clinical Trial Versus Real-World Outcomes With Anti-VEGF Therapy for Central Retinal Vein Occlusion
Author Affiliations & Notes
  • Robert B Bhisitkul
    Ophthalmology, University California-San Francisco, San Francisco, California, United States
  • Steven Blotner
    Genentech, Inc., South San Francisco, California, United States
  • Verena Steffen
    Genentech, Inc., South San Francisco, California, United States
  • Zdenka Haskova
    Genentech, Inc., South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Robert Bhisitkul, Genentech/Roche (F), Rezolute (C), RIBOMIC, Inc. (C), Visgenx (C), Zordera (I), Zordera (P); Steven Blotner, Genentech, Inc. (E); Verena Steffen, Genentech, Inc. (E); Zdenka Haskova, Genentech, Inc. (E)
  • Footnotes
    Support  Genentech, Inc. (South San Francisco, CA, USA) provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation.
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 1304. doi:
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    • Get Citation

      Robert B Bhisitkul, Steven Blotner, Verena Steffen, Zdenka Haskova; Clinical Trial Versus Real-World Outcomes With Anti-VEGF Therapy for Central Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2020;61(7):1304.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To assess the impact of monitoring and anti–vascular endothelial growth factor (VEGF) injection frequency on vision outcomes in patients with macular edema due to central retinal vein occlusion (CRVO).

Methods : We performed cross-trial comparisons between studies that assessed intravitreal anti-VEGF therapy in patients with macular edema due to CRVO. Data extracted from published literature were used to compare average injection frequencies and best-corrected visual acuity (BCVA) outcomes achieved with as-needed (PRN), treat-and-extend, and real-world (per investigator discretion) anti-VEGF dosing regimens over 12 months. Cross-trial comparisons were limited by differences in patient population, sample size, and treatment protocols across studies.

Results : Analyses included 4 randomized controlled trials, 1 open-label trial, 4 long-term extension (LTE) studies, and 3 real-world studies. There was a trend for higher injection frequencies and better vision outcomes in clinical trials versus LTE and real-world studies. Among clinical trial subgroups who received near-monthly monitoring, the average number of injections ranged between 7.8–11.8 over the first 12 months of treatment. In comparison, LTE and real-world study participants had less-frequent visits and received 3.3–4.5 and 3.3–6.0 injections over 12 months, respectively. With frequent injections and regular monitoring, estimated mean BCVA gains over 12 months ranged between 10.7–21.9 letters across clinical trial subgroups; however, these gains were not maintained, on average, in subsequent LTE studies (mean BCVA change across trials, –7.6 to +1.5 letters over 12 months). On average, less-frequent anti-VEGF dosing in real-world CRVO subgroups was associated with lower mean vision gains over 12 months (1.4–13.2 letters).

Conclusions : In real-world and LTE studies, patients with macular edema due to CRVO had less-frequent visits, received fewer anti-VEGF injections, and did not maintain or achieve vision gains observed in pivotal trials. These data highlight the need for new strategies that extend the durability of treatment for macular edema in CRVO to reduce treatment burden and improve real-world vision outcomes.

This is a 2020 ARVO Annual Meeting abstract.

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