Cited by 2,669Retinal Diseases and TreatmentsRetinal and Macular SurgeryOcular Diseases and Behçet’s Syndrome

Ranibizumab and bevacizumab for neovascular age-related macular degeneration

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The CATT Research Group·2011·New England Journal of Medicine

Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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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  • A subsequent comparison study of ranibizumab and bevacizumab for neovascular AMD reported rates of 0.16% for ranibizumab and 0.5% for bevacizumab.

    “The MARINA and ANCHOR trials with ranibizumab showed an incidence of 0.05% [30, 31], and a subsequent comparison study of ranibizumab and bevacizumab for neovascular AMD reported rates of 0.16% for ranibizumab and 0.5% for bevacizumab [32].”

    From Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review (2021) · cites this paper as [32]

    The Results, under Adverse Events (page not provided), report endophthalmitis after 0.04% of ranibizumab injections and 0.07% of bevacizumab injections, not 0.16% and 0.5%. The source is the comparison study described, but its reported rates differ from those attributed to it. (LLM, conf=0.87)

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  • More than 92% of CATT participants had stable or improved VA relative to baseline.

    “The majority of CATT participants (>92%) had stable or improved VA relative to baseline.”

    From Pharmacogenetics for Genes Associated with Age-related Macular Degeneration in the Comparison of AMD Treatments Trials (CATT) (2013) · cites this paper as [1]

    The Results (Mean Change in Visual Acuity; page unavailable) report improved mean visual acuity in all four CATT groups. The Discussion defines maintained acuity as losing fewer than 15 letters, which can include a decline from baseline. Neither passage establishes that more than 92% of individual participants had unchanged or improved acuity. (LLM, conf=0.83)

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  • CATT showed that bevacizumab was equivalent to ranibizumab in improving VA in neovascular AMD when given monthly or PRN.

    “The Comparison of AMD Treatments Trials (CATT) showed that bevacizumab was equivalent to ranibizumab in improving visual acuity (VA) of patients with neovascular AMD when treatment was administered either monthly or pro re nata (PRN).1”
  • There was a wide range in treatment response despite the overall clinical effect.

    “However, despite this remarkable clinical effect, there was a wide range in treatment response.”
  • At one year, monthly bevacizumab and ranibizumab groups gained 8.0 and 8.5 letters, respectively, while PRN groups gained 5.9 and 6.8 letters.

    “At one year, participants treated monthly with bevacizumab or ranibizumab gained 8.0 and 8.5 letters, respectively, and those treated as needed gained 5.9 and 6.8 letters, respectively.”

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Authors
The CATT Research Group
Corresponding author
The CATT Research Group
Venue
New England Journal of Medicine
Published
2011-05-19
Volume
364
Issue
20
Pages
1897-1908
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W1481978003
Cited by
2,669
References
21
Citations by year
2026: 78 · 2025: 91 · 2024: 116 · 2023: 111 · 2022: 127 · 2021: 164 · 2020: 195 · 2019: 151 · 2018: 168 · 2017: 177 · 2016: 199 · 2015: 238 · 2014: 264 · 2013: 248 · 2012: 265
FWCI
254.47
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Eye Institute (U10EY017825, U10EY017826, U10EY017823, U10EY017828)
Topics
  • Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Retinal and Macular Surgery
  • Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
Keywords
neovascular age-related macular degeneration, ranibizumab, bevacizumab, intravitreal injection, anti-VEGF therapy, visual acuity, central retinal thickness, treatment schedule, non-inferiority, serious adverse events, off-label drug use, anti-angiogenic therapy, comparative efficacy and safety, hospitalization
MeSH terms
Bevacizumab, Ranibizumab, Aged, Aged, 80 and over, Antibodies, Monoclonal, Cardiovascular Diseases, Drug Administration Schedule, Female, Humans, Macular Degeneration, Male, Middle Aged, Retina, Therapeutic Equivalency, Visual Acuity, Proportional Hazards Models, Single-Blind Method, Off-Label Use, Intention to Treat Analysis, Antibodies, Monoclonal, Humanized

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