Evaluation of very high-and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration

Quan Dong Nguyen, Peter A. Campochiaro, Syed Mahmood Shah, David J. Browning, Henry L. Hudson, Peter L. Sonkin, Seenu M. Hariprasad, Peter K. Kaiser, Jason Slakter, Julia A. Haller, Diana V. Do, William Mieler, Karen Chu, Avner Ingerman, Robert Vitti, Alyson J. Berliner, Jesse Cedarbaum

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Abstract

Purpose: To determine bioactivity and duration of effect of intravitreal aflibercept injection (also known as vascular endothelial growth factor Trap-Eye) for neovascular age-related macular degeneration (AMD). Methods: In this double-masked, phase 1 study, 28 patients with lesions ≤12 disc areas, ≥50% active choroidal neovascularization (CNV), and best corrected visual acuity (BCVA) ≤20/40 were randomized 1:1 to a single intravitreal injection of aflibercept 0.15 or 4mg. The primary end point was the change from baseline in central retinal/lesion thickness (CR/LT) at week-8. Secondary outcomes were the change from baseline BCVA, the change in CNV lesion size and area of leakage, and proportion of patients requiring repeat injection at 8 weeks. Results: Mean percent decrease in CR/LT for the 4-mg and 0.15-mg groups was, respectively, 34.2 versus 13.3 at week 4 (P=0.0065), 23.8 versus 5.9 at week 6 (P=0.0380), and 25.2% versus 11.3% at week 8 (P=0.150). The 4-mg group gained a mean of 4.5 letters in BCVA (6/14 patients gaining ≥10 letters) versus 1.1 letters in 0.15-mg group (1/14 gaining ≥10 letters) at week 8. Fewer patients needed retreatment in the 4-mg group at week 8. No serious adverse event or ocular inflammation was reported in either group. Conclusions: Intravitreal aflibercept 4mg had a safety profile similar to that of the very low dose 0.15mg, and was well-tolerated. The 4-mg dose significantly reduced foveal thickening at weeks 4 and 6, significantly improved BCVA at weeks 6, and reduced the need for repeat injection after 8 weeks compared with intravitreal aflibercept 0.15mg in neovascular AMD patients.

Original languageEnglish (US)
Pages (from-to)581-588
Number of pages8
JournalJournal of Ocular Pharmacology and Therapeutics
Volume28
Issue number6
DOIs
StatePublished - Dec 1 2012

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ASJC Scopus subject areas

  • Ophthalmology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Nguyen, Q. D., Campochiaro, P. A., Shah, S. M., Browning, D. J., Hudson, H. L., Sonkin, P. L., Hariprasad, S. M., Kaiser, P. K., Slakter, J., Haller, J. A., Do, D. V., Mieler, W., Chu, K., Ingerman, A., Vitti, R., Berliner, A. J., & Cedarbaum, J. (2012). Evaluation of very high-and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration. Journal of Ocular Pharmacology and Therapeutics, 28(6), 581-588. https://doi.org/10.1089/jop.2011.0261