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

Authors

• 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

Publication/Presentation Date

12-1-2012

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 4 mg. 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 4 mg had a safety profile similar to that of the very low dose 0.15 mg, 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 0.15 mg in neovascular AMD patients.

Volume

28

Issue

6

First Page

581

Last Page

588

ISSN

1557-7732

Published In/Presented At

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., & Clear-It 1 Investigators (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 : the official journal of the Association for Ocular Pharmacology and Therapeutics, 28(6), 581–588. https://doi.org/10.1089/jop.2011.0261

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

22775078

Department(s)

Administration and Leadership

Document Type

Article