One‐Year Effectiveness Study of Intravitreous Ranibizumab in Wet (Neovascular) Age‐Related Macular Degeneration: A Meta‐Analysis

Guo, Michael; Etminan, Mahyar; Cheng, Jasmine; Zafarí, Zafar; Maberley, David

doi:10.1002/phar.2079

Cited by 5 publications

(6 citation statements)

References 51 publications

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“…Improvements of BCVA were associated with significant reductions of CSFT and CSV in each study arm, without differences among the treatment regimens used. These findings are consistent with a large body of evidence of the efficacy of ranibizumab in nAMD reported in the literature (Rosenfeld et al 2006;Brown et al 2009; Comparison of Age-Related Macular Degeneration Treatment Trials (CATT) Research Group 2016; Vardarinos et al 2017;Ozkaya et al 2017;Silva et al 2017;Guo et al 2018). However, to the best of our knowledge, this is the first prospective randomized trial comparing the clinical efficacy and safety of three regimens, bimonthly, T&E and PRN in treatment-na€ ıve patients with nAMD.…”

Section: Discussionsupporting

confidence: 89%

Bimonthly, treat‐and‐extend and as‐needed ranibizumab in naïve neovascular age‐related macular degeneration patients: 12‐month outcomes of a randomized study

Gálvez

Barquet

Figueroa

et al. 2020

Acta Ophthalmologica

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To assess the noninferiority of the treat-and-extend (T&E) and fixed bimonthly regimens of 0.5 mg intravitreal ranibizumab as compared with the pro re nata (PRN) in na€ ıve patients with neovascular age-related macular degeneration (nAMD). Methods: Phase IV, randomized, 12-month, multicentre trial. Patients aged ≥50 years with nAMD and visual impairment [best-corrected visual acuity (BCVA) between 23 and 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] were eligible. Patients (one eye per patient) were randomized to bimonthly, n = 103, T&E, n = 99 or PRN, n = 104. Noninferiority was established at five letters ETDRS. Results: The mean (95% CI) difference in BCVA at 12 months was 7.2 (4.2-10.2), 6.4 (2.9-9.8), and 8.0 (51.1-11.0) in the bimonthly, T&E and PRN, respectively. The bimonthly or T&E regimens were not inferior to the PRN scheme. All regimens were associated with a significant reduction of central subfield thickness and volume. The mean (95% CI) number of injections in the bimonthly regimen (7.6, 7.5-7.7) was similar as compared with the PRN regimen (7.4, 6.7-8.0) (p = 0.159) but lower than in the T&E regimen (9.3, 8.9-9.7) (p < 0.001). Conclusion: At 12 months, bimonthly and T&E ranibizumab were noninferior to PRN in na€ ıve nAMD. Key words: best-corrected visual acuity-fixed bimonthly-intravitreal anti-VEGF-neovascular age-related macular degeneration-pro re nata-ranibizumab-treat-and-extend † The In-Eye Study Group members are listed in Appendix 1.

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Section: Discussionsupporting

confidence: 89%

Bimonthly, treat‐and‐extend and as‐needed ranibizumab in naïve neovascular age‐related macular degeneration patients: 12‐month outcomes of a randomized study

Gálvez

Barquet

Figueroa

et al. 2020

Acta Ophthalmologica

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“…(See Appendix 1D in the supplementary material.) The mean gain in VA estimated in this analysis is supported by the results from other RBZ real-world meta-analyses (Kim et al [10], Guo et al [11]) that estimated mean gains in VA at week 52 ranging between ? 4.85 to ?…”

Section: Discussionsupporting

confidence: 84%

“…AURA also showed that several factors, including age, baseline VA score, number of injections, and regular monitoring, may be predictive of treatment outcomes and may explain the differences between real-world outcomes and RCTs [9]. Since these studies were undertaken, clinical practice has evolved; recent meta-analyses of RBZ real-world studies [10,11] showed that VA outcomes at 12 months in RBZ-treated patients were improved compared with those in AURA. Despite these improvements, treatment outcomes varied between studies, and the mean VA gain was lower in observational studies than in RCTs.…”

Section: Introductionmentioning

confidence: 99%

Real-World Effectiveness and Real-World Cost-Effectiveness of Intravitreal Aflibercept and Intravitreal Ranibizumab in Neovascular Age-Related Macular Degeneration: Systematic Review and Meta-Analysis of Real-World Studies

et al. 2019

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Introduction: Treatment of neovascular agerelated macular degeneration (nAMD) has evolved with the advent of anti-vascular endothelial growth factor agents such that intravitreally administered aflibercept and ranibizumab (RBZ) have become the standard of care. Randomized clinical trials (RCTs) have demonstrated the benefits of these agents in nAMD; however, results achieved under RCT protocols may not always be replicated in clinical practice. Assessing real-world outcomes is important to estimate the effectiveness and cost-effectiveness of these two agents. Our objective was to assess the real-world effectiveness of intravitreally administered aflibercept and RBZ in treatment-naive patients with nAMD and determine the cost-effectiveness of intravitreally administered aflibercept versus RBZ in a real-world setting. Methods: A multistage approach was undertaken. A systematic literature review (SLR) was completed to identify studies describing realworld outcomes in patients with nAMD treated intravitreally with aflibercept or RBZ. A metaanalysis of data identified in the SLR generated a pooled estimate of the effectiveness of intravitreally administered aflibercept and RBZ at 52 weeks and an estimate of treatment burden (injection frequency and monitoring). The impact of treatment effect modifiers, such as baseline visual acuity (VA) and age, were corrected through a multivariable meta-regression. A Markov state transition model was developed to estimate the real-world cost-effectiveness of intravitreally administered aflibercept using results from the pooled estimates for effectiveness and treatment burden as primary inputs. The analysis considered the perspective of the French National Healthcare System. Results: Patients treated intravitreally with aflibercept had a mean age of 79.52 years and mean baseline VA of 55.80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. At week 52, mean VA gain was 5.30 ETDRS letters in patients reporting an average of 7.10 intravitreal injections of aflibercept and 8.65 visits Enhanced Digital Features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.10098272.

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Section: Resultsmentioning

confidence: 95%

“…Guo et al reported an improvement of +4.85 letters after 1 year in 37 observational studies with ranibizumab treatment (which included fixed-dose and PRN regimens). 29 Similarly, Kim et al reported an increase of +3.5 letters at Year 1 with ranibizumab PRN regimens (N=20 247); however, this was not maintained, reducing to +1.3 letters at Year 2 and −1.9 letters by Year 3 (N=14 408 and 11 714, respectively). 30 Three articles reported outcomes for studies including >1000 patients on PRN regimens (AURA, LUMINOUS and IRIS) and, in all, improvements in VA were observed with ranibizumab PRN treatment at 1 year compared with baseline.…”

Section: Anti-vegf Treatment In Pro Re Nata (Prn; As Needed) Regimensmentioning

confidence: 95%

Evolution of treatment paradigms in neovascular age-related macular degeneration: a review of real-world evidence

et al. 2020

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The aim of this work was to evaluate the contribution of real-world evidence (RWE) in changing anti-vascular endothelial growth factor (VEGF) therapy treatment practices and improving real-world treatment strategies for neovascular age-related macular degeneration (nAMD).A PubMed literature search was performed to review the large number of English-language studies conducted to investigate the real-world effectiveness of anti-VEGF (aflibercept and ranibizumab) treatment paradigms available for nAMD.The evidence for pro re nata (PRN), treat-and-extend (T&E) and fixed bimonthly dosing regimens for anti-VEGF treatment of nAMD were reviewed and findings are summarised. RWE demonstrated that T&E regimens optimise visual outcomes while reducing burden on patients, clinics and physicians, compared with both fixed-dose and PRN regimens.RWE has helped to develop and improve real-world treatment strategies in nAMD, with the aim of optimising visual outcomes and reducing treatment burden in clinical practice. Of the various regimens, a T&E regimen is most likely to adequately balance clinical outcomes and treatment burden for patients with nAMD.

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One‐Year Effectiveness Study of Intravitreous Ranibizumab in Wet (Neovascular) Age‐Related Macular Degeneration: A Meta‐Analysis

Abstract: This meta-analysis suggests visual improvements at 12 months of 0.5-mg ranibizumab use in patients with wAMD. A higher gain in VA was observed when pooling results from RCTs compared to those in observational studies.

Cited by 5 publications

References 51 publications

Bimonthly, treat‐and‐extend and as‐needed ranibizumab in naïve neovascular age‐related macular degeneration patients: 12‐month outcomes of a randomized study

Bimonthly, treat‐and‐extend and as‐needed ranibizumab in naïve neovascular age‐related macular degeneration patients: 12‐month outcomes of a randomized study

Real-World Effectiveness and Real-World Cost-Effectiveness of Intravitreal Aflibercept and Intravitreal Ranibizumab in Neovascular Age-Related Macular Degeneration: Systematic Review and Meta-Analysis of Real-World Studies

Evolution of treatment paradigms in neovascular age-related macular degeneration: a review of real-world evidence

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