Efficacy and Frequency of Intravitreal Aflibercept Versus Bevacizumab for Macular Edema Secondary to Central Retinal Vein Occlusion

“…Nonetheless, the visual gains of the first year reduced in a similar fashion to COPERNICUS at the 18-month study end-point [7,8,11]. Since then, other trials have investigated different loading periods, follow up intervals and more recently, treat-and-extend protocols [12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 91%

A treat and extend protocol with Aflibercept for cystoid macular oedema secondary to central retinal vein occlusion – an 18-month prospective cohort study

et al. 2020

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Background: To evaluate the safety and efficacy of a treat-and-extend protocol of aflibercept for cystoid macular oedema (CMO) secondary to central retinal vein occlusion (CRVO). Methods: Twenty patients with CMO secondary to CRVO were included in this prospective cohort study. After 3 loading 4-weekly injections, treatment intervals were increased by 2 weeks if there was no clinical activity, to a maximum of 12 weeks. If clinical activity recurred or persisted, the interval between injections was shortened by 2 weeks, to a minimum of 4 weeks. Main outcome measures were change in visual acuity and the proportion of patients gaining 15 or more Early Treatment of Diabetic Retinopathy Study (ETDRS) letters from baseline at 6, 12 and 18 months. Results: Mean BCVA gain from baseline was 19.7 ± 13.8, 22.2 ± 13.9 and 21.9 ± 15.8 ETDRS letters at 6, 12 and 18 months, respectively. Sixty-five percent of patients gained 15 or more ETDRS letters at 6 months, increasing to 70.6% at 12 and 18 months. Patients received 5.0 [4.0 to 6.0], 8.5 [8.0 to 10.3] and 11.0 [9.0 to 12.5] injections by 6, 12 and 18 months, respectively. Conclusions: The visual outcomes achieved with a treat-and-extend protocol in this study were similar to the pivotal trials of aflibercept for CMO secondary to CRVO, which used monthly and then as-needed protocols.

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“…58 A RCT comparing aflibercept and bevacizumab on a one plus pro re nata basis found that those in the aflibercept arm required fewer injections at 12 months. 59 The COMRADE-C trial was a Phase IIIb, multicentre, double-masked, randomised clinical trial that compared a ranibizumab loading phase followed by pro re nata dosing with 0.7 mg of dexamethasone, given only at baseline, for MO due to CRVO, and showed a favourable outcome with ranibizumab. 60 A 2019 systematic review 61 evaluating the effectiveness and adverse effects of ranibizumab, aflibercept and bevacizumab in three common retinal conditions, including RVO, reported that none of the 17 included studies showed a clinically important difference (i.e.…”

Section: Evidence Update Post Leavo Initiationmentioning

confidence: 99%

“…It was not possible to perform a safety meta-analysis because of the lack of comparative outcome data for anti-VEGF therapy in CRVO. Two other comparative studies were completed during LEAVO: the multicentre SCORE2 27 clinical trial, which compared aflibercept and bevacizumab, given by mandated monthly injection over 6 months, and a small comparative study 59 of aflibercept versus bevacizumab in 50 patients with MO due to CRVO who were followed up for 12 months. The latter trial did not publish any tabulated AE data and was discounted.…”

Section: Safety Meta-analysismentioning

confidence: 99%

Intravitreal ranibizumab versus aflibercept versus bevacizumab for macular oedema due to central retinal vein occlusion: the LEAVO non-inferiority three-arm RCT

Hykin

Prevost

Sivaprasad

et al. 2021

Health Technol Assess

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Background Licensed ranibizumab (0.5 mg/0.05 ml Lucentis®; Novartis International AG, Basel, Switzerland) and aflibercept (2 mg/0.05 ml Eylea®; Bayer AG, Leverkusen, Germany) and unlicensed bevacizumab (1.25 mg/0.05 ml Avastin®; F. Hoffmann-La Roche AG, Basel, Switzerland) are used to treat macula oedema due to central retinal vein occlusion, but their relative clinical effectiveness, cost-effectiveness and impact on the UK NHS and Personal Social Services have never been directly compared over the typical disease treatment period. Objective The objective was to compare the clinical effectiveness and cost-effectiveness of three intravitreal antivascular endothelial growth factor agents for the management of macula oedema due to central retinal vein occlusion. Design This was a three-arm, double-masked, randomised controlled non-inferiority trial. Setting The trial was set in 44 UK NHS ophthalmology departments, between 2014 and 2018. Participants A total of 463 patients with visual impairment due to macula oedema secondary to central retinal vein occlusion were included in the trial. Interventions The participants were treated with repeated intravitreal injections of ranibizumab (n = 155), aflibercept (n = 154) or bevacizumab (n = 154). Main outcome measures The primary outcome was an increase in the best corrected visual acuity letter score from baseline to 100 weeks in the trial eye. The null hypothesis that aflibercept and bevacizumab are each inferior to ranibizumab was tested with a non-inferiority margin of –5 visual acuity letters over 100 weeks. Secondary outcomes included additional visual acuity, and imaging outcomes, Visual Function Questionnaire-25, EuroQol-5 Dimensions with and without a vision bolt-on, and drug side effects. Cost-effectiveness was estimated using treatment costs and Visual Function Questionnaire-Utility Index to measure quality-adjusted life-years. Results The adjusted mean changes at 100 weeks in the best corrected visual acuity letter scores were as follows – ranibizumab, 12.5 letters (standard deviation 21.1 letters); aflibercept, 15.1 letters (standard deviation 18.7 letters); and bevacizumab, 9.8 letters (standard deviation 21.4 letters). Aflibercept was non-inferior to ranibizumab in the intention-to-treat population (adjusted mean best corrected visual acuity difference 2.23 letters, 95% confidence interval –2.17 to 6.63 letters; p = 0.0006), but not superior. The study was unable to demonstrate that bevacizumab was non-inferior to ranibizumab in the intention-to-treat population (adjusted mean best corrected visual acuity difference –1.73 letters, 95% confidence interval –6.12 to 2.67 letters; p = 0.071). A post hoc analysis was unable to demonstrate that bevacizumab was non-inferior to aflibercept in the intention-to-treat population (adjusted mean best corrected visual acuity difference was –3.96 letters, 95% confidence interval –8.34 to 0.42 letters; p = 0.32). All per-protocol population results were the same. Fewer injections were required with aflibercept (10.0) than with ranibizumab (11.8) (difference in means –1.8, 95% confidence interval –2.9 to –0.8). A post hoc analysis showed that more bevacizumab than aflibercept injections were required (difference in means 1.6, 95% confidence interval 0.5 to 2.7). There were no new safety concerns. The model- and trial-based cost-effectiveness analyses estimated that bevacizumab was the most cost-effective treatment at a threshold of £20,000–30,000 per quality-adjusted life-year. Limitations The comparison of aflibercept and bevacizumab was a post hoc analysis. Conclusion The study showed aflibercept to be non-inferior to ranibizumab. However, the possibility that bevacizumab is worse than ranibizumab and aflibercept by 5 visual acuity letters cannot be ruled out. Bevacizumab is an economically attractive treatment alternative and would lead to substantial cost savings to the NHS and other health-care systems. However, uncertainty about its relative effectiveness should be discussed comprehensively with patients, their representatives and funders before treatment is considered. Future work To obtain extensive patient feedback and discuss with all stakeholders future bevacizumab NHS use. Trial registration Current Controlled Trials ISRCTN13623634. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 38. See the NIHR Journals Library website for further project information.

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Efficacy and Frequency of Intravitreal Aflibercept Versus Bevacizumab for Macular Edema Secondary to Central Retinal Vein Occlusion

Abstract: Both aflibercept and bevacizumab are comparably effective for treatment of macular edema secondary to central retinal vein occlusion without significant complications. However, the burden of frequent intravitreal injections could be significantly reduced when using aflibercept.

Cited by 18 publications

References 14 publications

Effect of funding source on reporting bias in studies of intravitreal anti‐vascular endothelial growth factor therapy for retinal vein occlusion

Effect of funding source on reporting bias in studies of intravitreal anti‐vascular endothelial growth factor therapy for retinal vein occlusion

A treat and extend protocol with Aflibercept for cystoid macular oedema secondary to central retinal vein occlusion – an 18-month prospective cohort study

Intravitreal ranibizumab versus aflibercept versus bevacizumab for macular oedema due to central retinal vein occlusion: the LEAVO non-inferiority three-arm RCT

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