SUSPENDING TREATMENT OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN CASES OF FUTILITY

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Abstract

This publication summarizes the recommendations of the Vision Academy Steering Committee for the management of neovascular age-related macular degeneration in patients with poor response to anti–vascular endothelial growth factor therapy, considering factors that lead to suboptimal responses in clinical practice and providing guidance for alternative anti–vascular endothelial growth factor treatment strategies ahead of suspending treatment in cases of futility.

Abstract

Purpose:

To provide guidance on the management of patients with neovascular age-related macular degeneration and its subtypes who respond poorly to anti–vascular endothelial growth factor (anti-VEGF) therapy, and to identify cases where suspending anti-VEGF treatment may be warranted.

Methods:

Through a literature review and the combined knowledge and clinical experience of retinal experts, the Steering Committee of the Bayer-sponsored Vision Academy developed an algorithm for determining when to suspend anti-VEGF treatment of neovascular age-related macular degeneration in cases of futility.

Results:

Consideration of factors that may cause suboptimal response to anti-VEGF therapy, such as undertreatment or misdiagnosis of the underlying condition, and factors that may preclude continued treatment, such as injection- or drug-induced complications, is necessary for adjusting treatment protocols in patients who respond poorly to anti-VEGF. If poor response to treatment persists after switching to an alternative anti-VEGF agent and no change in response is observed after withholding treatment for a predetermined period of time (“treatment pause”), anti-VEGF treatment may be considered futile and should be suspended.

Conclusion:

This publication introduces an algorithm to guide the management of neovascular age-related macular degeneration in patients showing poor response to anti-VEGF treatment and provides expert guidance for suspending anti-VEGF treatment in cases of futility.

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Most cited references 44

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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 injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies.

Ursula Schmidt-Erfurth, Peter K Kaiser, Jean-François Korobelnik … (2014)

To determine efficacy and safety of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) during a second year of variable dosing after a first-year fixed-dosing period. Two randomized, double-masked, active-controlled, phase 3 trials. Two thousand four hundred fifty-seven patients with neovascular AMD. From baseline to week 52, patients received 0.5 mg intravitreal ranibizumab every 4 weeks (Rq4), 2 mg aflibercept every 4 weeks (2q4), 0.5 mg aflibercept every 4 weeks (0.5q4), or 2 mg aflibercept every 8 weeks (2q8) after 3 monthly injections. During weeks 52 through 96, patients received their original dosing assignment using an as-needed regimen with defined retreatment criteria and mandatory dosing at least every 12 weeks. Proportion of eyes at week 96 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA. Proportions of eyes maintaining BCVA across treatments were 94.4% to 96.1% at week 52 and 91.5% to 92.4% at week 96. Mean BCVA gains were 8.3 to 9.3 letters at week 52 and 6.6 to 7.9 letters at week 96. Proportions of eyes without retinal fluid decreased from week 52 (60.3% to 72.4%) to week 96 (44.6% to 54.4%), and more 2q4 eyes were without fluid at weeks 52 and 96 than Rq4 eyes (difference of 10.4% [95% confidence interval {CI}, 4.9-15.9] and 9.0% [95% CI, 3.0-15.1]). Patients received on average 16.5, 16.0, 16.2, and 11.2 injections over 96 weeks and 4.7, 4.1, 4.6, and 4.2 injections during weeks 52 through 96 in the Rq4, 2q4, 0.5q4, and 2q8 groups, respectively. The number of injections during weeks 52 through 96 was lower in the 2q4 and 2q8 groups versus the Rq4 group (differences of -0.64 [95% CI, -0.89 to -0.40] and -0.55 [95% CI, -0.79 to -0.30]; P < 0.0001, post hoc analysis). Incidences of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events were similar across groups (2.4% to 3.8%) from baseline to week 96. All aflibercept and ranibizumab groups were equally effective in improving BCVA and preventing BCVA loss at 96 weeks. The 2q8 aflibercept group was similar to ranibizumab in visual acuity outcomes during 96 weeks, but with an average of 5 fewer injections. Small losses at 96 weeks in the visual and anatomic gains seen at 52 weeks in all arms were in the range of losses commonly observed with variable dosing. Copyright © 2014 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature.

K Ghasemi Falavarjani, Anna Nguyen (2013)

Intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents is increasingly used for the treatment of a wide variety of retinal diseases, including age-related macular degeneration, diabetic retinopathy and retinal vascular occlusions, and retinopathy of prematurity. Despite encouraging results in halting the disease and improving the vision, intravitreal injection of anti-VEGF agents may be associated with systemic adverse events and devastating ocular complications. In this review, we provide an overview of safety data for intravitreal injection of common anti-VEGF agents.

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Author and article information

Journal

Journal ID (nlm-ta): Retina

Journal ID (iso-abbrev): Retina (Philadelphia, Pa.)

Journal ID (publisher-id): retina

Title: Retina (Philadelphia, Pa.)

Publisher: Retina

ISSN (Print): 0275-004X

ISSN (Electronic): 1539-2864

Publication date (Print): June 2020

Publication date (Electronic): 24 December 2019

Volume: 40

Issue: 6

Pages: 1010-1020

Affiliations

[* ]University of Toronto, Toronto, ON, Canada;

[† ]St. Michael's Hospital, Toronto, ON, Canada;

[‡ ]Global Medical Affairs Ophthalmology, Bayer, Switzerland;

[§ ]Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel;

[¶ ]Royal Liverpool University Hospital, Liverpool, United Kingdom; and

[** ]Kyorin University School of Medicine, Tokyo, Japan.

Author notes

Reprint requests: David T. Wong, MD, Department of Ophthalmology and Vision Sciences, University of Toronto, St. Michael's Hospital, 801-61 Queen Street East, Toronto, ON, Canada, M5C 2T2; e-mail: David.wong@ 123456unityhealth.to

Article

Publisher ID: Retina-218-2220 Accession ID: 00002

DOI: 10.1097/IAE.0000000000002713

PMC ID: 7448759

PubMed ID: 31876889

SO-VID: 9ecf9983-c2de-4acc-bf92-bb732d232fe4

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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Keywords: amd,anti-vegf,neovascular age-related macular degeneration,treatment futility,vision academy

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Keywords: amd, anti-vegf, neovascular age-related macular degeneration, treatment futility, vision academy

SUSPENDING TREATMENT OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN CASES OF FUTILITY

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Most cited references 44

Ranibizumab and bevacizumab for neovascular age-related macular degeneration.

Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies.

Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature.

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