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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.
Curr Eye Res. 2020 05; 45(5):604-614.CE

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.

Authors+Show Affiliations

Hannover Medical School, University Eye Hospital, Hannover, Germany. Eye Center, University Medical Center Freiburg, Freiburg, Germany.Eye Hospital, University Medical Center, Goettingen, Germany.Eye Hospital, Klinikum Ludwigshafen, Ludwigshafen, Germany.Eye Hospital, University Medical Center, Goettingen, Germany.Eye Hospital, University Medical Center, Goettingen, Germany.Department of Ophthalmology, Novartis Pharma GmbH, Nuremberg, Germany.Department of Ophthalmology, Novartis Pharma GmbH, Nuremberg, Germany.Department of Ophthalmology, University Eye Hospital, Ludwig Maximilian Universität, München, Germany.Department of Ophthalmology, University Eye Hospital Ulm, Ulm, Germany.Eye Hospital, University of Bonn and GRADE Reading Center, Bonn, Germany.Department of Ophthalmology, University Eye Hospital, Ludwig Maximilian Universität, München, Germany.Eye Hospital, Universitätsklinikum Leipzig, Leipzig, Germany.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31665935

Citation

Pielen, Amelie, et al. "Ranibizumab Pro Re Nata Versus Dexamethasone in the Management of Ischemic Retinal Vein Occlusion: Post-hoc Analysis From the COMRADE Trials." Current Eye Research, vol. 45, no. 5, 2020, pp. 604-614.
Pielen A, Feltgen N, Hattenbach LO, et al. Ranibizumab Pro Re nata versus Dexamethasone in the Management of Ischemic Retinal Vein Occlusion: Post-hoc Analysis from the COMRADE Trials. Curr Eye Res. 2020;45(5):604-614.
Pielen, A., Feltgen, N., Hattenbach, L. O., Hoerauf, H., Bertelmann, T., Quiering, C., Vögeler, J., Priglinger, S., Lang, G. E., Schmitz-Valckenberg, S., Wolf, A., & Rehak, M. (2020). Ranibizumab Pro Re nata versus Dexamethasone in the Management of Ischemic Retinal Vein Occlusion: Post-hoc Analysis from the COMRADE Trials. Current Eye Research, 45(5), 604-614. https://doi.org/10.1080/02713683.2019.1679839
Pielen A, et al. Ranibizumab Pro Re Nata Versus Dexamethasone in the Management of Ischemic Retinal Vein Occlusion: Post-hoc Analysis From the COMRADE Trials. Curr Eye Res. 2020;45(5):604-614. PubMed PMID: 31665935.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ranibizumab Pro Re nata versus Dexamethasone in the Management of Ischemic Retinal Vein Occlusion: Post-hoc Analysis from the COMRADE Trials. AU - Pielen,Amelie, AU - Feltgen,Nicolas, AU - Hattenbach,Lars-Olof, AU - Hoerauf,Hans, AU - Bertelmann,Thomas, AU - Quiering,Claudia, AU - Vögeler,Jessica, AU - Priglinger,Siegfried, AU - Lang,Gabriele E, AU - Schmitz-Valckenberg,Steffen, AU - Wolf,Armin, AU - Rehak,Matus, Y1 - 2019/10/31/ PY - 2019/11/2/pubmed PY - 2021/7/10/medline PY - 2019/11/1/entrez KW - COMRADE KW - Ranibizumab KW - ischemia KW - nonperfusion KW - retinal vein occlusion SP - 604 EP - 614 JF - Current eye research JO - Curr Eye Res VL - 45 IS - 5 N2 - 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. SN - 1460-2202 UR - https://www.unboundmedicine.com/medline/citation/31665935/Ranibizumab_Pro_Re_nata_versus_Dexamethasone_in_the_Management_of_Ischemic_Retinal_Vein_Occlusion:_Post_hoc_Analysis_from_the_COMRADE_Trials_ L2 - https://www.tandfonline.com/doi/full/10.1080/02713683.2019.1679839 DB - PRIME DP - Unbound Medicine ER -