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Ranibizumab Pro Re nata versus Dexamethasone in the Management of Ischemic Retinal Vein Occlusion: Post-hoc Analysis from the COMRADE Trials.

Authors
  • Pielen, Amelie1, 2
  • Feltgen, Nicolas3
  • Hattenbach, Lars-Olof4
  • Hoerauf, Hans3
  • Bertelmann, Thomas3
  • Quiering, Claudia5
  • Vögeler, Jessica5
  • Priglinger, Siegfried6
  • Lang, Gabriele E7
  • Schmitz-Valckenberg, Steffen8
  • Wolf, Armin6
  • Rehak, Matus9
  • 1 Hannover Medical School, University Eye Hospital, Hannover, Germany. , (Germany)
  • 2 Eye Center, University Medical Center Freiburg, Freiburg, Germany. , (Germany)
  • 3 Eye Hospital, University Medical Center, Goettingen, Germany. , (Germany)
  • 4 Eye Hospital, Klinikum Ludwigshafen, Ludwigshafen, Germany. , (Germany)
  • 5 Department of Ophthalmology, Novartis Pharma GmbH, Nuremberg, Germany. , (Germany)
  • 6 Department of Ophthalmology, University Eye Hospital, Ludwig Maximilian Universität, München, Germany. , (Germany)
  • 7 Department of Ophthalmology, University Eye Hospital Ulm, Ulm, Germany. , (Germany)
  • 8 Eye Hospital, University of Bonn and GRADE Reading Center, Bonn, Germany. , (Germany)
  • 9 Eye Hospital, Universitätsklinikum Leipzig, Leipzig, Germany. , (Germany)
Type
Published Article
Journal
Current Eye Research
Publisher
Informa UK (Informa Healthcare)
Publication Date
May 01, 2020
Volume
45
Issue
5
Pages
604–614
Identifiers
DOI: 10.1080/02713683.2019.1679839
PMID: 31665935
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Purpose: To compare ischemia-related clinical outcomes in patients treated with either ranibizumab pro re nata (PRN) or single dexamethasone implant in the Branch Retinal Vein Occlusion (COMRADE-B) or Central Retinal Vein Occlusion (COMRADE-C) trials.Methods: A post-hoc analysis of the Phase IIIb, 6-month, multicenter, double-masked, randomized, COMRADE-B and COMRADE-C trials. Change over 6 months in retinal ischemia status (central avascular [CA] zone and peripheral nonperfusion [PNP]), mean best-corrected visual acuity (BCVA), the development of shunt vessels and neovascularization, and frequency of laser therapy were assessed in retinal vein occlusion (RVO) patients treated with either ranibizumab 0.5 mg PRN or single dexamethasone 0.7 mg implant, as per European labels, in the COMRADE-B (N = 244; ranibizumab, 126, dexamethasone, 118) or COMRADE-C (N = 243; ranibizumab, 124, dexamethasone, 119) trials. BCVA progression in ischemic vs. non-ischemic patients based on the ischemia assessment at month 6 was carried out.Results: Visual acuity (VA) gains from baseline to month 6 were higher with ranibizumab than with dexamethasone in both patients with central ischemia and those with peripheral retinal nonperfusion, independent of the type of RVO (branch or central). The presence of CA and PNP had a significant impact on VA gain over 6 months in CRVO patients (p < .0001), while there was no significant impact in BRVO. Ranibizumab was associated with less new ischemia than dexamethasone. Central RVO patients treated with dexamethasone received more laser treatments over the 6 months than those treated with ranibizumab, while there was no difference in the frequency of laser therapy between the branch RVO treatment groups.Conclusions: VA gain over six months in ranibizumab-treated RVO patients is not affected by ischemia, and is associated with less development of new ischemia during the first 6 months of treatment and equal or fewer laser treatments than dexamethasone implant.

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