Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD): Interim (month 6) analysis of clinical safety and efficacy

Donald J. D'Amico, Morton F Goldberg, Henry Hudson, Janice A. Jerdan, Scott Krueger, Susan Luna, Stella M. Robertson, Stephen Russell, Lawrence Singerman, Jason S. Slakter, E. Kenneth Sullivan, Lawrence Yannuzzi, Patricia Zilliox

Research output: Contribution to journalArticle

Abstract

Purpose: To evaluate clinical safety and efficacy of the angiostatic agent anecortave acetate for treatment of subfoveal choroidal neovascularization secondary to AMD. Methods: 128 patients were randomized to placebo treatment or one of three anecortave acetate doses. Study medication was administered as a posterior juxtascleral injection onto the posterior scleral surface. Best-corrected logMAR vision was obtained at baseline and follow-up visits. Fluorescein angiograms were evaluated for eligibility before enrollment and posttreatment. Results: Six months after a single treatment, visual acuity (mean change from baseline logMAR values) was significantly better (P = 0.003) after anecortave acetate 15 mg than placebo. More patients treated with anecortave acetate 15 mg than placebo maintained vision (88% versus 70%, P = 0.080), especially those with predominantly classic lesions (92% versus 65%, P = 0.021). Anecortave acetate 15 mg inhibited lesion growth significantly better than placebo (P = 0.001). Trends favoring the other doses over placebo were observed for vision preservation and lesion inhibition, but statistical significance was not achieved. The Independent Safety Committee overseeing this study identified no clinically relevant treatment-related changes. Conclusion: Anecortave acetate 15 mg is safe and effective for preserving or improving vision and for inhibiting lesion growth in patients with subfoveal AMD.

Original languageEnglish (US)
Pages (from-to)14-23
Number of pages10
JournalRetina
Volume23
Issue number1
DOIs
StatePublished - Feb 2003

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Macular Degeneration
Safety
Placebos
Therapeutics
Choroidal Neovascularization
Angiogenesis Inhibitors
Growth
Fluorescein
Visual Acuity
anecortave acetate
Angiography
Injections

Keywords

  • Age-related macular degeneration (AMD)
  • Anecortave acetate
  • Angiogenesis
  • Angiostatic agents
  • Choroidal neovascularization (CNV)

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems

Cite this

Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD) : Interim (month 6) analysis of clinical safety and efficacy. / D'Amico, Donald J.; Goldberg, Morton F; Hudson, Henry; Jerdan, Janice A.; Krueger, Scott; Luna, Susan; Robertson, Stella M.; Russell, Stephen; Singerman, Lawrence; Slakter, Jason S.; Kenneth Sullivan, E.; Yannuzzi, Lawrence; Zilliox, Patricia.

In: Retina, Vol. 23, No. 1, 02.2003, p. 14-23.

Research output: Contribution to journalArticle

D'Amico, DJ, Goldberg, MF, Hudson, H, Jerdan, JA, Krueger, S, Luna, S, Robertson, SM, Russell, S, Singerman, L, Slakter, JS, Kenneth Sullivan, E, Yannuzzi, L & Zilliox, P 2003, 'Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD): Interim (month 6) analysis of clinical safety and efficacy', Retina, vol. 23, no. 1, pp. 14-23. https://doi.org/10.1097/00006982-200302000-00003
D'Amico, Donald J. ; Goldberg, Morton F ; Hudson, Henry ; Jerdan, Janice A. ; Krueger, Scott ; Luna, Susan ; Robertson, Stella M. ; Russell, Stephen ; Singerman, Lawrence ; Slakter, Jason S. ; Kenneth Sullivan, E. ; Yannuzzi, Lawrence ; Zilliox, Patricia. / Anecortave acetate as monotherapy for the treatment of subfoveal lesions in patients with exudative age-related macular degeneration (AMD) : Interim (month 6) analysis of clinical safety and efficacy. In: Retina. 2003 ; Vol. 23, No. 1. pp. 14-23.
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abstract = "Purpose: To evaluate clinical safety and efficacy of the angiostatic agent anecortave acetate for treatment of subfoveal choroidal neovascularization secondary to AMD. Methods: 128 patients were randomized to placebo treatment or one of three anecortave acetate doses. Study medication was administered as a posterior juxtascleral injection onto the posterior scleral surface. Best-corrected logMAR vision was obtained at baseline and follow-up visits. Fluorescein angiograms were evaluated for eligibility before enrollment and posttreatment. Results: Six months after a single treatment, visual acuity (mean change from baseline logMAR values) was significantly better (P = 0.003) after anecortave acetate 15 mg than placebo. More patients treated with anecortave acetate 15 mg than placebo maintained vision (88{\%} versus 70{\%}, P = 0.080), especially those with predominantly classic lesions (92{\%} versus 65{\%}, P = 0.021). Anecortave acetate 15 mg inhibited lesion growth significantly better than placebo (P = 0.001). Trends favoring the other doses over placebo were observed for vision preservation and lesion inhibition, but statistical significance was not achieved. The Independent Safety Committee overseeing this study identified no clinically relevant treatment-related changes. Conclusion: Anecortave acetate 15 mg is safe and effective for preserving or improving vision and for inhibiting lesion growth in patients with subfoveal AMD.",
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T2 - Interim (month 6) analysis of clinical safety and efficacy

AU - D'Amico, Donald J.

AU - Goldberg, Morton F

AU - Hudson, Henry

AU - Jerdan, Janice A.

AU - Krueger, Scott

AU - Luna, Susan

AU - Robertson, Stella M.

AU - Russell, Stephen

AU - Singerman, Lawrence

AU - Slakter, Jason S.

AU - Kenneth Sullivan, E.

AU - Yannuzzi, Lawrence

AU - Zilliox, Patricia

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N2 - Purpose: To evaluate clinical safety and efficacy of the angiostatic agent anecortave acetate for treatment of subfoveal choroidal neovascularization secondary to AMD. Methods: 128 patients were randomized to placebo treatment or one of three anecortave acetate doses. Study medication was administered as a posterior juxtascleral injection onto the posterior scleral surface. Best-corrected logMAR vision was obtained at baseline and follow-up visits. Fluorescein angiograms were evaluated for eligibility before enrollment and posttreatment. Results: Six months after a single treatment, visual acuity (mean change from baseline logMAR values) was significantly better (P = 0.003) after anecortave acetate 15 mg than placebo. More patients treated with anecortave acetate 15 mg than placebo maintained vision (88% versus 70%, P = 0.080), especially those with predominantly classic lesions (92% versus 65%, P = 0.021). Anecortave acetate 15 mg inhibited lesion growth significantly better than placebo (P = 0.001). Trends favoring the other doses over placebo were observed for vision preservation and lesion inhibition, but statistical significance was not achieved. The Independent Safety Committee overseeing this study identified no clinically relevant treatment-related changes. Conclusion: Anecortave acetate 15 mg is safe and effective for preserving or improving vision and for inhibiting lesion growth in patients with subfoveal AMD.

AB - Purpose: To evaluate clinical safety and efficacy of the angiostatic agent anecortave acetate for treatment of subfoveal choroidal neovascularization secondary to AMD. Methods: 128 patients were randomized to placebo treatment or one of three anecortave acetate doses. Study medication was administered as a posterior juxtascleral injection onto the posterior scleral surface. Best-corrected logMAR vision was obtained at baseline and follow-up visits. Fluorescein angiograms were evaluated for eligibility before enrollment and posttreatment. Results: Six months after a single treatment, visual acuity (mean change from baseline logMAR values) was significantly better (P = 0.003) after anecortave acetate 15 mg than placebo. More patients treated with anecortave acetate 15 mg than placebo maintained vision (88% versus 70%, P = 0.080), especially those with predominantly classic lesions (92% versus 65%, P = 0.021). Anecortave acetate 15 mg inhibited lesion growth significantly better than placebo (P = 0.001). Trends favoring the other doses over placebo were observed for vision preservation and lesion inhibition, but statistical significance was not achieved. The Independent Safety Committee overseeing this study identified no clinically relevant treatment-related changes. Conclusion: Anecortave acetate 15 mg is safe and effective for preserving or improving vision and for inhibiting lesion growth in patients with subfoveal AMD.

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