June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Branch and central retinal vein occlusion: clinical pearls from trials of ranibizumab
Author Affiliations & Notes
  • Mimi Liu
    Colorado Retina Associates, Denver, Colorado, United States
  • David Eichenbaum
    Retina Vitreous Associates of Florida, Tampa, Florida, United States
  • Sarah Taylor
    Genentech, Inc., South San Francisco, California, United States
  • Pin-wen Wang
    Genentech, Inc., South San Francisco, California, United States
  • Carlos Quezada-Ruiz
    Genentech, Inc., South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Mimi Liu, Roche (C); David Eichenbaum, Alcon Laboratories, Inc. (F), Alimera Sciences, Inc. (C), Alimera Sciences, Inc. (F), Allergan (C), Allergan (F), Genentech, Inc (C), Genentech, Inc. (F), Hemera Biosciences (F), Ophthotech (F), Regeneron Pharmaceuticals, Inc. (C), Thrombogenics, Inc. (C), TOGA Trial (F), US Retina (F); Sarah Taylor, Genentech, Inc. (E); Pin-wen Wang, Genentech, Inc. (E); Carlos Quezada-Ruiz, 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 June 2017, Vol.58, 4624. doi:
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    • Get Citation

      Mimi Liu, David Eichenbaum, Sarah Taylor, Pin-wen Wang, Carlos Quezada-Ruiz; Branch and central retinal vein occlusion: clinical pearls from trials of ranibizumab. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4624.

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Abstract

Purpose : To review key clinical takeaways of ranibizumab (RBZ) treatment for patients (pts) with branch RVO (BRVO) or central RVO (CRVO) in the BRAVO, CRUISE, SHORE, BRIGHTER, and CRYSTAL studies.

Methods : BRAVO/CRUISE were phase 3, randomized US studies that evaluated RBZ for the treatment of macular edema secondary to BRVO (N=397) and CRVO (N=392), respectively. Pts received monthly therapy from months (M) 0-5 and criteria-based (PRN) therapy from M6-11. SHORE was a phase 4, randomized US study that evaluated monthly and PRN dosing in pts with BRVO (n=115) and CRVO (n=87). Pts received a minimum of 7 monthly RBZ 0.5-mg injections (inj) and were then randomized to continue RBZ monthly (n=85) or switched to PRN RBZ (n=86) the first month that pre-specified disease stability criteria were met. BRIGHTER/CRYSTAL were phase 3b, open-label, ex-US clinical trials of RBZ for pts with BRVO (N=455) and CRVO (N=357), respectively. Pts in the RBZ 0.5-mg treatment arms received a minimum of 3 monthly RBZ inj and were then switched to PRN dosing based on pre-specified disease stability criteria.

Results : In BRAVO, CRUISE, and SHORE, the proportion of RBZ-treated pts who gained ≥15 ETDRS letters at M6 were 57.9%-63.4%, 46.3%-50.5%, and 67.6%, respectively. The median time to first gain of ≥15 ETDRS letters from baseline in RBZ-treated pts was 4.0-4.8M in BRAVO, 5.2-5.9M in CRUISE, and 2.1M in SHORE. Rapid anatomic improvements were seen after 1 RBZ inj, with the average reduction in retinal thickness exceeding 200 μm in BRAVO, CRUISE, and SHORE. Vision gains achieved with monthly dosing were maintained over time with individualized, less-than-monthly PRN treatment in BRAVO/CRUISE (mean 2.8-3.6 inj/6M PRN), and SHORE (3.7 inj/8M PRN). RBZ treatment was also effective in pts with macular ischemia at baseline; in BRIGHTER and CRYSTAL, ischemic pts treated with RBZ 0.5 mg gained +14.3 and +11.2 letters from baseline at M6, respectively.

Conclusions : In BRAVO, CRUISE, SHORE, BRIGHTER, and CRYSTAL, RBZ was shown to be an effective treatment for pts with ischemic and nonischemic BRVO and CRVO. Across the trials, RBZ worked rapidly, resulted in clinically significant vision gains and anatomic improvements, and worked on a PRN basis following disease stabilization.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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