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Cited by 2,337Retinal Diseases and TreatmentsRetinal and Macular SurgeryOcular Diseases and Behçet’s Syndrome

Pegaptanib for neovascular age-related macular degeneration

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Gragoudas, Evangelos S., Adamis, Anthony P., Cunningham, Emmett T., Feinsod, Matthew, Guyer, David R.·2004·New England Journal of Medicine
DOI 10.1056/nejmoa042760
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Abstract

BACKGROUND: Pegaptanib, an anti-vascular endothelial growth factor therapy, was evaluated in the treatment of neovascular age-related macular degeneration. METHODS: 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. RESULTS: 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. CONCLUSIONS: Pegaptanib appears to be an effective therapy for neovascular age-related macular degeneration. Its long-term safety is not known.

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  • Pegaptanib was the first anti-VEGF therapy approved for intravitreal injection in 2004, but is no longer utilized due to superior efficacy of newer anti-VEGF agents.

    “Of note, pegaptanib (Macugen, Eyetech/OIS Pharmaceuticals, Melville, NY) was in fact the first anti-VEGF therapy approved for intravitreal injection in 2004, however it is no longer utilized due to the superior efficacy of newer anti-VEGF agents [10].”

    From Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review (2021) · cites this paper as [10]

    The Abstract (page unavailable) identifies pegaptanib as an anti-VEGF therapy administered by intravitreous injection. The paper does not establish that it was the first such therapy approved in 2004, or that it is no longer used because newer agents are more effective; its Results instead report benefit from pegaptanib versus sham injection. (LLM, conf=0.87)

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  • Repeated intravitreal injections of anti-VEGF therapies effectively slow vision loss in the majority of treatment-compliant patients with wet AMD.

    “Repeated intravitreal (IVT) injections of anti-VEGF therapies effectively slow vision loss in the majority of treatment-compliant patients with wet AMD. 7 – 13”

    From Design and Characterization of a Novel Intravitreal Dual-Transgene Genetic Medicine for Neovascular Retinopathies (2024) · cites this paper as [9]

  • No evidence of baseline serum anti-pegaptanib IgG and IgM antibodies was detectable throughout the first year of treatment in the VISION trial.

    “No evidence of baseline serum anti-pegaptanib IgG and IgM antibodies was detectable throughout the first year of treatment in the VISION trial [10].”

    From Mechanisms of sterile inflammation after intravitreal injection of antiangiogenic drugs: a narrative review (2021) · cites this paper as [10]

    The Results section reports visual-acuity outcomes through week 54 and injection-related adverse events, but does not report serum anti-pegaptanib antibody testing. Searches for IgG, IgM, antibodies, and immunogenicity found no passage establishing whether these antibodies were detectable at baseline or during the first year. (LLM, conf=0.72)

    Experimental — accuracy not yet measured

  • Major anti-VEGF trials other than CATT did not enroll patients with neovascular AMD whose hemorrhage exceeded half of the total CNV lesion.

    “Other major anti-VEGF clinical trials excluded such patients.18,19,20”

    From Development and Course of Scars in the Comparison of Age-Related Macular Degeneration Treatments Trials (2018) · cites this paper as [18]

    The Study Design section says lesions containing blood were permitted up to a total size of 12 optic-disk areas, but it gives no limit on hemorrhage as a proportion of the lesion. Searches for hemorrhage, blood, and an exclusion threshold did not find a passage establishing that patients whose hemorrhage exceeded half the lesion were excluded. (LLM, conf=0.73)

    Experimental — accuracy not yet measured

  • Vision was stabilised in 70% of patients treated with pegaptanib compared with 55% of patients receiving placebo.

    “Vision was stabilised in 70% of patients treated with pegaptanib compared with 55% of patients receiving placebo.163”

    From Age-related macular degeneration (2008) · cites this paper as [163]

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Research works printed but not linked: 4

  1. Folkman J. Tumor angiogenesis: thera- peutic implications. N Engl J Med 1971;285: 1182-6.
  2. www.nejm.org december 30 , 2004 2816 pegaptanib for age-related macular degeneration the 1992
  3. Lorenz E. Zimmerman Lecture. Ophthalmology 1993;100:1519-35.
  4. Ishida S, Usui T, Yamashiro K, et al. VEGF164 is proinflammatory in the diabetic retina. Invest Ophthalmol Vis Sci 2003;44: 2155-62.

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Authors
Gragoudas, E. S., Adamis, A. P., Cunningham, E. T., Feinsod, M., & Guyer, D. R.
Affiliations
Massachusetts Eye and Ear Infirmary (US)
ORCID
Gragoudas, Evangelos S.
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2004-12-30
Volume
351
Issue
27
Pages
2805-2816
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa042760
OpenAlex
W1802218256
Cited by
2,337
References
25
Citations by year
2026: 48 · 2025: 74 · 2024: 56 · 2023: 65 · 2022: 56 · 2021: 61 · 2020: 58 · 2019: 54 · 2018: 63 · 2017: 62 · 2016: 72 · 2015: 85 · 2014: 119 · 2013: 107 · 2012: 137
FWCI
199.00
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • UvA-DARE (University of Amsterdam) (publishedVersion)
  • Pure Amsterdam UMC (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
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
pegaptanib, neovascular age-related macular degeneration, anti-VEGF therapy, intravitreal injection, visual acuity, dose-response relationship, endophthalmitis, retinal detachment, adverse events, treatment efficacy, retinal neovascularization, choroidal neovascularization, macular edema, retinal pigment epithelium
MeSH terms
Aged, Aged, 80 and over, Double-Blind Method, Female, Humans, Injections, Macular Degeneration, Male, Middle Aged, Oligonucleotides, Photochemotherapy, Prospective Studies, Radiography, Visual Acuity, Vitreous Body, Choroidal Neovascularization, Vascular Endothelial Growth Factor A, Aptamers, Nucleotide

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