Document Type
Article
Journal Title
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics
Publication Date
12-2012
Volume
28
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.
MeSH Headings
Aged, Aged, 80 and over, Choroidal Neovascularization, Dose-Response Relationship, Drug, Double-Blind Method, Female, Fovea Centralis, Humans, Intravitreal Injections, Macular Degeneration, Male, Middle Aged, Prospective Studies, Receptors, Vascular Endothelial Growth Factor, Recombinant Fusion Proteins, Treatment Outcome, Visual Acuity
DOI Link
ISSN
1557-7732
Recommended Citation
Dong Nguyen, Quan; Campochiaro, Peter A.; Shah, Syed Mahmood; Browning, David J.; Hudson, Henry L.; Sonkin, Peter L.; Hariprasad, Seenu M.; Kaiser, Peter K.; Slakter, Jason; Haller, Julia A.; Do, Diana V.; Mieler, William; Chu, Karen; Ingerman, Avner; Vitti, Robert; Berliner, Alyson J.; Cedarbaum, Jesse; and CLEAR-IT 1 Investigators, "Evaluation of very high- and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration." (2012). Journal Articles: Ophthalmology. 8.
https://digitalcommons.unmc.edu/com_eye_articles/8
Supplemental Data
Comments
This is a copy of an article published in the Journal of Ocular Pharmacology and Therapeutics © 2012 copyright Mary Ann Liebert, Inc.; Journal of Ocular Pharmacology and Therapeutics is available online at: http://online.liebertpub.com.