Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: Phase II study results

David R. Guyer, Gary Fish, Julia A. Haller, Allen C. Ho, Michael Klein, John Loewenstein, Daniel Martin, David Orth, Richard B. Rosen, Steve Sanislo, Steven D. Schwartz, Lawrence J. Singerman, George Williams

Research output: Contribution to journalArticle

302 Scopus citations

Abstract

Purpose: There is evidence to suggest that anti-vascular endothelial growth factor (anti-VEGF) therapy may be useful in treating ocular neovascularization. A phase IA single intravitreal injection study of anti-VEGF therapy for patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) revealed a good safety profile. We performed a phase II multiple injection study of anti-VEGF therapy with and without photodynamic therapy for patients with subfoveal CNV secondary to AMD to determine the safety profile of multiple injection therapy. Design: A phase II multiple-dose safety study. Participants/Methods: Twenty-one patients were treated with intravitreal injection with and without photodynamic therapy. Main Outcome Measures: Clinical evidence of toxicity and complications. Results: No drug-related serious adverse events were revealed. Ophthalmic evaluation revealed that 87.5% of patients who received the anti-VEGF aptamer alone showed stabilized or improved vision 3 months after treatment and that 25% of eyes demonstrated a 3 line or greater improvement in vision on the Early Treatment of Diabetic Retinopathy Study chart during this period. A 60% 3 line gain at 3 months was noted in patients who received both the anti-VEGF aptamer and photodynamic therapy. Conclusions: Anti-VEGF therapy is a promising treatment for various forms of ocular neovascularization, including AMD. Multiple intravitreal injections of the anti-VEGF aptamer were well tolerated in this phase II study. Further clinical trials are necessary to demonstrate the efficacy and long-term safety of anti-VEGF therapy for AMD.

Original languageEnglish (US)
Pages (from-to)979-986
Number of pages8
JournalOphthalmology
Volume110
Issue number5
DOIs
StatePublished - May 1 2003

ASJC Scopus subject areas

  • Ophthalmology

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    Guyer, D. R., Fish, G., Haller, J. A., Ho, A. C., Klein, M., Loewenstein, J., Martin, D., Orth, D., Rosen, R. B., Sanislo, S., Schwartz, S. D., Singerman, L. J., & Williams, G. (2003). Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: Phase II study results. Ophthalmology, 110(5), 979-986. https://doi.org/10.1016/S0161-6420(03)00085-X