Ziv-aflibercept and bevacizumab for exudative age-related macular degeneration: A retrospective comparison of clinical outcomes and cost at 1 year

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Abstract

PURPOSE:

The purpose of this study was to compare intravitreal ziv-aflibercept (IVZ) monotherapy to intravitreal bevacizumab (IVB) monotherapy in patients with exudative age-related macular degeneration (eAMD).

MATERIALS AND METHODS:

Patients with treatment-naïve eAMD treated with pro re nata (PRN) monotherapy of IVZ (1.25 mg/0.05 ml) or IVB (1.25 mg/0.05 ml) with a minimum follow-up of 12 months were retrospectively analyzed. Study outcomes included change in best-corrected visual acuity (BCVA), central macular thickness, mean number of injections, and total medication cost in both the groups at 12 months.

RESULTS:

Forty-seven eyes (IVZ, 18/47 [38.3%] and IVB, 29/47 [61.7%]) from 47 treatment-naive patients were included. The change in BCVA for patients receiving IVZ was from 0.61 ± 0.33 logarithm of the minimum angle of resolution (Snellen 20/81; range: 20/38–20/174) to 0.45 ± 0.31 (Snellen 20/56; range: 20/27–20/115) at 1 year ( P = 0.02). The total number of injections needed to achieve the resolution of intraretinal or subretinal fluid was 2.6 ± 1.4 and 3.5 ± 1.3 for IVZ and IVB, respectively ( P = 0.029). Direct medication cost of IVZ and IVB in our cohort on PRN basis was an average of US$78 (2.6 × US$30) and US$175 (3.5 × US$50), respectively, through 1 year.

CONCLUSION:

IVZ-PRN monotherapy resulted in improved visual acuity, reduced treatment burden, and reduced direct medication cost in comparison to IVB-PRN monotherapy through 1 year.

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Most cited references 17

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Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis.

Wan Wong, Xinyi Su, Xiang Li … (2014)

Numerous population-based studies of age-related macular degeneration have been reported around the world, with the results of some studies suggesting racial or ethnic differences in disease prevalence. Integrating these resources to provide summarised data to establish worldwide prevalence and to project the number of people with age-related macular degeneration from 2020 to 2040 would be a useful guide for global strategies. We did a systematic literature review to identify all population-based studies of age-related macular degeneration published before May, 2013. Only studies using retinal photographs and standardised grading classifications (the Wisconsin age-related maculopathy grading system, the international classification for age-related macular degeneration, or the Rotterdam staging system) were included. Hierarchical Bayesian approaches were used to estimate the pooled prevalence, the 95% credible intervals (CrI), and to examine the difference in prevalence by ethnicity (European, African, Hispanic, Asian) and region (Africa, Asia, Europe, Latin America and the Caribbean, North America, and Oceania). UN World Population Prospects were used to project the number of people affected in 2014 and 2040. Bayes factor was calculated as a measure of statistical evidence, with a score above three indicating substantial evidence. Analysis of 129,664 individuals (aged 30-97 years), with 12,727 cases from 39 studies, showed the pooled prevalence (mapped to an age range of 45-85 years) of early, late, and any age-related macular degeneration to be 8.01% (95% CrI 3.98-15.49), 0.37% (0.18-0.77), and 8.69% (4.26-17.40), respectively. We found a higher prevalence of early and any age-related macular degeneration in Europeans than in Asians (early: 11.2% vs 6.8%, Bayes factor 3.9; any: 12.3% vs 7.4%, Bayes factor 4.3), and early, late, and any age-related macular degeneration to be more prevalent in Europeans than in Africans (early: 11.2% vs 7.1%, Bayes factor 12.2; late: 0.5% vs 0.3%, 3.7; any: 12.3% vs 7.5%, 31.3). There was no difference in prevalence between Asians and Africans (all Bayes factors <1). Europeans had a higher prevalence of geographic atrophy subtype (1.11%, 95% CrI 0.53-2.08) than Africans (0.14%, 0.04-0.45), Asians (0.21%, 0.04-0.87), and Hispanics (0.16%, 0.05-0.46). Between geographical regions, cases of early and any age-related macular degeneration were less prevalent in Asia than in Europe and North America (early: 6.3% vs 14.3% and 12.8% [Bayes factor 2.3 and 7.6]; any: 6.9% vs 18.3% and 14.3% [3.0 and 3.8]). No significant gender effect was noted in prevalence (Bayes factor <1.0). The projected number of people with age-related macular degeneration in 2020 is 196 million (95% CrI 140-261), increasing to 288 million in 2040 (205-399). These estimates indicate the substantial global burden of age-related macular degeneration. Summarised data provide information for understanding the effect of the condition and provide data towards designing eye-care strategies and health services around the world. National Medical Research Council, Singapore. Copyright © 2014 Wong et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by .. All rights reserved.

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Ranibizumab and bevacizumab for neovascular age-related macular degeneration.

Daniel Martin, Maureen Maguire, Gui-shuang Ying … (2011)

Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data. In a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a noninferiority limit of 5 letters on the eye chart. Bevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern. At 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.).

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Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration.

Jeffrey Heier, David M Brown, Victor Chong … (2012)

Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Proprietary or commercial disclosure may be found after the references. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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Author and article information

Journal

Journal ID (nlm-ta): Taiwan J Ophthalmol

Journal ID (iso-abbrev): Taiwan J Ophthalmol

Journal ID (publisher-id): TJO

Title: Taiwan Journal of Ophthalmology

Publisher: Wolters Kluwer - Medknow (India )

ISSN (Print): 2211-5056

ISSN (Electronic): 2211-5072

Publication date Collection: Oct-Dec 2020

Publication date (Electronic): 27 April 2020

Volume: 10

Issue: 4

Pages: 289-293

Affiliations

[1 ] Smt Kanuri Santhamma Centre for Vitreoretinal Diseases, L V Prasad Eye Institute, Hyderabad, India

[2 ] Vitreous Retina Macula Consultants of New York, New York, USA

[3 ] Lu Esther T. Mertz Retinal Research Center New York, NY, USA

[4 ] Retina Service, Massachusetts Eye and Ear/Harvard Medical School, Department of Ophthalmology, Boston, MA, USA

[5 ] Department of Ophthalmology, Faculty of Medicine, Yamanashi University, Yamanashi, Japan

[6 ] Department of Ophthalmology, Rafic Hariri Medical University Beirut, Lebanon

[7 ] Department of Ophthalmology, New York University School of Medicine, New York, USA

Author notes

[* ] Address for correspondence: Dr. Jay Chhablani, L. V. Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, Hyderabad - 500 034, Telangana, India. E-mail: jay.chhablani@ 123456gmail.com

[#]

Both contributed equally to the manuscript as first author

Article

Publisher ID: TJO-10-289

DOI: 10.4103/tjo.tjo_3_20

PMC ID: 7787097

SO-VID: c801e76d-df77-4c24-bc3a-b0bb17e8e16c

License:

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

Ziv-aflibercept and bevacizumab for exudative age-related macular degeneration: A retrospective comparison of clinical outcomes and cost at 1 year

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Abstract

PURPOSE:

MATERIALS AND METHODS:

RESULTS:

CONCLUSION:

Related collections

Karger: Ophthalmology

Most cited references 17

Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis.

Ranibizumab and bevacizumab for neovascular age-related macular degeneration.

Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration.

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