Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study

Hoerauf, Hans; Feltgen, Nicolas; Weiß, Claudia; Paulus, Eva‐Maria; Schmitz-Valckenberg, Steffen; Pielen, Amelie; Puri, Pankaj; Berk, Hüsnü; Eter, Nicole; Wiedemann, Peter; Lang, Gabriele E.; Rehák, Matúš; Wolf, Armin; Bertelmann, Thomas; Hattenbach, Lars‐Olof

doi:10.1016/j.ajo.2016.04.020

Cited by 70 publications

(88 citation statements)

References 20 publications

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“…The ranibizumab group had significantly better BCVA gains at 3 and 6 months postinjection. At the 6-month follow-up, the ranibizu mab group also had a significantly higher mean average BCVA gain [16] .…”

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confidence: 90%

Intravitreal Dexamethasone Implant versus Intravitreal Ranibizumab for the Treatment of Macular Edema Secondary to Retinal Vein Occlusion in a Chinese Population

Yu²,

Song³

et al. 2017

Ophthalmic Res

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Background: The aim of this work was to compare the efficacy of intravitreal dexamethasone implant (Ozurdex) and intravitreal ranibizumab (Lucentis) in the treatment of macular edema (ME) caused by retinal vein occlusion (RVO). Methods: Thirty-two ME cases treated with Ozurdex and 32 ME cases treated with ranibizumab were enrolled, with 26 central (C)RVO and 6 branch (B)RVO subjects in each group. We compared the results of best-corrected visual acuity (BCVA), central retinal thickness, number of injections, and intraocular pressure (IOP) at 1, 2, 3, and 6 months after injection. Results: BCVA in both groups at each follow-up were significantly increased compared to baseline with no statistical difference between the groups. Ozurdex and ranibizumab successfully reduced CMT at each follow-up. Both CRVO and BRVO patients had significant between-group differences in the mean number of injections. Among the CRVO patients, IOP in the Ozurdex group was significantly increased compared to baseline and the ranibizumab group at 1, 2, and 3 months postinjection. Conclusions: Intravitreal injection of Ozurdex and ranibizumab can effectively control ME secondary to RVO and increase a patient's BCVA. The advantages of Ozurdex are fewer injections and longer efficacy, while the advantages of ranibizumab include fewer side effects.

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confidence: 90%

Intravitreal Dexamethasone Implant versus Intravitreal Ranibizumab for the Treatment of Macular Edema Secondary to Retinal Vein Occlusion in a Chinese Population

Yu²,

Song³

et al. 2017

Ophthalmic Res

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“…The statistical analysis was performed analogously to the core studies (Hoerauf et al 2016;Hattenbach et al 2018). All variables were analysed descriptively.…”

Section: Statistical Analysesmentioning

confidence: 99%

“…The incidence of ocular treatment-emergent adverse events (TEAEs) and of increases in IOP was higher with DEX than with ranibizumab (Hoerauf et al 2016;Hattenbach et al 2018). The primary analyses showed significantly better visual outcomes for ranibizumab at 6 months in both indications.…”

Section: Introductionmentioning

confidence: 97%

“…Ranibizumab (Lucentis Ò ; Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA) (EMA 2014) and the slowrelease dexamethasone implant (DEX implant; Ozurdex Ò ; Allergan Inc., Irvine, CA, USA, and Allergan Pharmaceuticals, Dublin, Ireland) (EMA 2010) are both approved for the treatment of macular oedema secondary to RVO. The two COMRADE core trials, conducted from 2011 to 2014, were the first head-to-head comparisons of ranibizumab and DEX in patients presenting visual impairment due to macular oedema secondary to BRVO (COM-RADE-B) (Hattenbach et al 2018) and CRVO (COMRADE-C) (Hoerauf et al 2016). In this context, it has been repeatedly debated whether the higher number of ranibizumab injections or the known side effects of DEX [cataract and increased intraocular pressure (IOP)] should be regarded as the more disadvantageous (Pielen et al 2013;Reid et al 2015).…”

Section: Introductionmentioning

confidence: 99%

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Comparison of ranibizumab versus dexamethasone for macular oedema following retinal vein occlusion: 1‐year results of the COMRADE extension study

Feltgen

Hattenbach

Bertelmann

et al. 2018

Acta Ophthalmologica

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When used according to the European labels, ranibizumab revealed a better ocular safety profile and produced greater average BCVA gains than DEX. By the end of the additional 6-month study period, this difference in BCVA was more pronounced in BRVO as in CRVO patients. The main limitation of the COMRADE studies was that DEX patients received only a single intravitreal treatment during the first 6 months, which is presumably not adequate. However, frequent DEX implants could lead to more steroid-related side effects, especially to an increased intraocular pressure.

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“…31 However, it is not commonly used as a first-line therapy for RVO-associated macular edema due to the higher reported rates of ocular adverse events, such as intraocular pressure elevation and cataract, associated with the dexamethasone implant than with anti-VEGF agents. 18–20, 31, 32, 33 …”

Section: Introductionmentioning

confidence: 99%

SCORE2 Report 2

VanVeldhuisen

Blodi

et al. 2017

Ophthalmology

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Objectives To describe the design and baseline characteristics of participants in the Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2) and to compare with cohorts from other retinal vein occlusion trials. Design Phase III prospective multicenter randomized clinical trial designed to assess whether intravitreal bevacizumab is non-inferior to intravitreal aflibercept for treatment of decreased vision attributable to macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO). Participants 362 participants, including 307 with CRVO and 55 with HRVO. Methods Demographic and study eye characteristics are summarized and compared between CRVO and HRVO study participants. Main outcome measures Baseline ophthalmic characteristics, including visual acuity and retinal thickness, and medical history characteristics, including hypertension, diabetes mellitus, and coronary artery disease. Results The mean age of participants was 69 years, 76% of participants were white, and 90% were non-Hispanic. There was a racial disparity with respect to disease type, with 38% of HRVO patients being black compared to 11% of CRVO patients (p-value adjusted for multiple testing=0.0001). This is similar to findings from the previous SCORE Study. Comorbidities included hypertension (77%), diabetes mellitus (31%) and coronary artery disease (15%). At baseline, mean visual acuity letter score (VALS) was 50 (20/100) (range: 19–73; 20/400-20/40), mean optical coherence tomography-measured central subfield thickness (OCT-CST) was 678 microns (range: 300–1203), and mean number of months from diagnosis of macular edema to randomization was 6 (range: 0–104). One hundred twenty (33%) SCORE2 participants had been treated previously with anti-VEGF therapy, with these participants having baseline VALS and OCT-CST similar to those without prior anti-VEGF treatment, but longer mean duration of macular edema before randomization (18 months versus 1 month for those without prior anti-VEGF treatment; p<0.0001). Conclusions The SCORE2 cohort is a heterogeneous population, including both CRVO and HRVO eyes and both treatment-naive eyes and eyes treated previously with anti-VEGF, which will allow study results to have broad applicability to CRVO and HRVO patients receiving treatment for macular edema. Similarities of the baseline characteristics of the SCORE2 population to other CRVO trial cohorts will allow meaningful comparisons of outcome results across trials.

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Clinical Efficacy and Safety of Ranibizumab Versus Dexamethasone for Central Retinal Vein Occlusion (COMRADE C): A European Label Study

Cited by 70 publications

References 20 publications

Intravitreal Dexamethasone Implant versus Intravitreal Ranibizumab for the Treatment of Macular Edema Secondary to Retinal Vein Occlusion in a Chinese Population

Intravitreal Dexamethasone Implant versus Intravitreal Ranibizumab for the Treatment of Macular Edema Secondary to Retinal Vein Occlusion in a Chinese Population

Comparison of ranibizumab versus dexamethasone for macular oedema following retinal vein occlusion: 1‐year results of the COMRADE extension study

SCORE2 Report 2

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