Quantifying the increasing use of
anti-vascular endothelial growth
factor therapy in ophthalmology

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Abstract

Introduction: Bevacizumab (Avastin; Genetech Inc., South San Francisco, CA) and ranibizumab (Lucentis, Genetech Inc.) are two anti-Vascular Endothelial Growth Factor (VEGF) agents used in increasing amounts off-label to treat ocular conditions. To date, no study has quantified how far reaching these therapies have been in treating eye disease and compared their off-label use to the number of clinical trials performed. Method: A systematic search of Ovid MEDLINE using the keywords bevacizumab and ranibizumab limited to “Case Reports” was used as an index of the number of diseases treated. Each keyword was also limited to “Clinical Trials, All” and “Phase III Clinical Trials” to discern the quality of evidence for these uses. Results: Bevacizumab has been utilized for the treatment of 58 different ocular conditions, but only 14 conditions were studied in a trial, and none were part of a phase III clinical trial. Ranibizumab has been used for 17 different eye conditions, with only 6 studied in a trial and only 1 disease, “wet” age-related macular degeneration reported in 4 phase III trials. In the case reports, there were 21 different adverse events ascribed to bevacizumab and 2 to ranibizumab with retinal pigment epithelial tears being the most common. Conclusion: Bevacizumab is one of the most far reaching drugs in ophthalmology and even medicine, but it is not yet supported by high quality evidence. The much higher cost of ranibizumab may be responsible for bevacizumab's popularity among eye specialists. Patients should be fully informed about the off-label use of bevacizumab and the associated risks with its use.

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Most cited references 53

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Prevalence of age-related macular degeneration in the United States.

David Friedman, Benita J O'Colmain, Beatriz Mateos Muñoz … (2004)

To estimate the prevalence and distribution of age-related macular degeneration (AMD) in the United States by age, race/ethnicity, and gender. Summary prevalence estimates of drusen 125 microm or larger, neovascular AMD, and geographic atrophy were prepared separately for black and white persons in 5-year age intervals starting at 40 years. The estimated rates were based on a meta-analysis of recent population-based studies in the United States, Australia, and Europe. These rates were applied to 2000 US Census data and to projected US population figures for 2020 to estimate the number of the US population with drusen and AMD. The overall prevalence of neovascular AMD and/or geographic atrophy in the US population 40 years and older is estimated to be 1.47% (95% confidence interval, 1.38%-1.55%), with 1.75 million citizens having AMD. The prevalence of AMD increased dramatically with age, with more than 15% of the white women older than 80 years having neovascular AMD and/or geographic atrophy. More than 7 million individuals had drusen measuring 125 microm or larger and were, therefore, at substantial risk of developing AMD. Owing to the rapidly aging population, the number of persons having AMD will increase by 50% to 2.95 million in 2020. Age-related macular degeneration was far more prevalent among white than among black persons. Age-related macular degeneration affects more than 1.75 million individuals in the United States. Owing to the rapid aging of the US population, this number will increase to almost 3 million by 2020.

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Causes and prevalence of visual impairment among adults in the United States.

Nathan Congdon, Benita J O'Colmain, Caroline C. W. Klaver … (2004)

To estimate the cause-specific prevalence and distribution of blindness and low vision in the United States by age, race/ethnicity, and gender, and to estimate the change in these prevalence figures over the next 20 years. Summary prevalence estimates of blindness (both according to the US definition of < or =6/60 [< or =20/200] best-corrected visual acuity in the better-seeing eye and the World Health Organization standard of < 6/120 [< 20/400]) and low vision (< 6/12 [< 20/40] best-corrected vision in the better-seeing eye) were prepared separately for black, Hispanic, and white persons in 5-year age intervals starting at 40 years. The estimated prevalences were based on recent population-based studies in the United States, Australia, and Europe. These estimates were applied to 2000 US Census data, and to projected US population figures for 2020, to estimate the number of Americans with visual impairment. Cause-specific prevalences of blindness and low vision were also estimated for the different racial/ethnic groups. Based on demographics from the 2000 US Census, an estimated 937 000 (0.78%) Americans older than 40 years were blind (US definition). An additional 2.4 million Americans (1.98%) had low vision. The leading cause of blindness among white persons was age-related macular degeneration (54.4% of the cases), while among black persons, cataract and glaucoma accounted for more than 60% of blindness. Cataract was the leading cause of low vision, responsible for approximately 50% of bilateral vision worse than 6/12 (20/40) among white, black, and Hispanic persons. The number of blind persons in the US is projected to increase by 70% to 1.6 million by 2020, with a similar rise projected for low vision. Blindness or low vision affects approximately 1 in 28 Americans older than 40 years. The specific causes of visual impairment, and especially blindness, vary greatly by race/ethnicity. The prevalence of visual disabilities will increase markedly during the next 20 years, owing largely to the aging of the US population.

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Pegaptanib for neovascular age-related macular degeneration.

Evangelos Gragoudas, Anthony P Adamis, Emmett Cunningham … (2004)

Pegaptanib, an anti-vascular endothelial growth factor therapy, was evaluated in the treatment of neovascular age-related macular degeneration. We conducted two concurrent, prospective, randomized, double-blind, multicenter, dose-ranging, controlled clinical trials using broad entry criteria. Intravitreous injection into one eye per patient of pegaptanib (at a dose of 0.3 mg, 1.0 mg, or 3.0 mg) or sham injections were administered every 6 weeks over a period of 48 weeks. The primary end point was the proportion of patients who had lost fewer than 15 letters of visual acuity at 54 weeks. In the combined analysis of the primary end point (for a total of 1186 patients), efficacy was demonstrated, without a dose-response relationship, for all three doses of pegaptanib (P<0.001 for the comparison of 0.3 mg with sham injection; P<0.001 for the comparison of 1.0 mg with sham injection; and P=0.03 for the comparison of 3.0 mg with sham injection). In the group given pegaptanib at 0.3 mg, 70 percent of patients lost fewer than 15 letters of visual acuity, as compared with 55 percent among the controls (P<0.001). The risk of severe loss of visual acuity (loss of 30 letters or more) was reduced from 22 percent in the sham-injection group to 10 percent in the group receiving 0.3 mg of pegaptanib (P<0.001). More patients receiving pegaptanib (0.3 mg), as compared with sham injection, maintained their visual acuity or gained acuity (33 percent vs. 23 percent; P=0.003). As early as six weeks after beginning therapy with the study drug, and at all subsequent points, the mean visual acuity among patients receiving 0.3 mg of pegaptanib was better than in those receiving sham injections (P<0.002). Among the adverse events that occurred, endophthalmitis (in 1.3 percent of patients), traumatic injury to the lens (in 0.7 percent), and retinal detachment (in 0.6 percent) were the most serious and required vigilance. These events were associated with a severe loss of visual acuity in 0.1 percent of patients. Pegaptanib appears to be an effective therapy for neovascular age-related macular degeneration. Its long-term safety is not known. Copyright 2004 Massachusetts Medical Society.

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Author and article information

Journal

Journal ID (nlm-ta): Mcgill J Med

Journal ID (iso-abbrev): Mcgill J Med

Journal ID (publisher-id): 9710939

Title: McGill Journal of Medicine : MJM

Publisher: McGill University

ISSN (Print): 1201-026X

ISSN (Electronic): 1201-026X

Publication date (Print): June 2011

Publication date (Electronic): June 2011

Volume: 13

Issue: 1

Electronic Location Identifier: 38

Author notes

Jonathan Micieli, MDCM (2012) is a medical student at McGill University and has receieved a B Sc. (Hons) from the University of Toronto in Laboratory Medicine and Pathobiology. He has had the opportunity to work on various projects regarding anti-angiogenic therapy for –wet– age-related macular degeneration and retinopathy of prematurity and has published on the topic in a number of peer-reviewed journals including the American Journal of Ophthalmology.

Andrew Micieli is an undergraduate student at the University of Toronto where he is studying Life Sciences. He has been involved in a number of research projects during his time in university including those that have evaluated the use of anti-angiogenic drugs in ophthalmology and other topics in this field.

[* ] To whom correspondence should be addressed: Jonathan A. Micieli 235 Rue Sherbrooke Ouest #207 Montreal, QC, H2X 1X8 jonathan.micieli@ 123456mail.mcgill.ca

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Publisher ID: mjm1301-038

PMC ID: 3399721

PubMed ID: 22815647

SO-VID: 65fdb3e3-05d0-4511-ad63-b0df3e587604

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This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License, which permits for noncommercial use, distribution, and reproduction in any digital medium, provided the original work is properly cited and is not altered in any way. For details, please refer to http://creativecommons.org/licenses/by-nc-nd/3.0/

Quantifying the increasing use of anti-vascular endothelial growth factor therapy in ophthalmology

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Clinical Virtual Research Center Journal of Ophthalmology

Most cited references 53

Prevalence of age-related macular degeneration in the United States.

Causes and prevalence of visual impairment among adults in the United States.

Pegaptanib for neovascular age-related macular degeneration.

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