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

Research output: Contribution to journalArticle

15 Citations (Scopus)

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

Fingerprint

Macular Degeneration
Visual Acuity
Choroidal Neovascularization
Intravitreal Injections
Injections
Retreatment
Double-Blind Method
Vascular Endothelial Growth Factor A
aflibercept
Inflammation
Safety

ASJC Scopus subject areas

  • Ophthalmology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Evaluation of very high-and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration. / Nguyen, Quan Dong; 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.

In: Journal of Ocular Pharmacology and Therapeutics, Vol. 28, No. 6, 01.12.2012, p. 581-588.

Research output: Contribution to journalArticle

Nguyen, QD, Campochiaro, PA, Shah, SM, Browning, DJ, Hudson, HL, Sonkin, PL, Hariprasad, SM, Kaiser, PK, Slakter, J, Haller, JA, Do, DV, Mieler, W, Chu, K, Ingerman, A, Vitti, R, Berliner, AJ & 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, vol. 28, no. 6, pp. 581-588. https://doi.org/10.1089/jop.2011.0261
Nguyen, Quan Dong ; 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. / Evaluation of very high-and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration. In: Journal of Ocular Pharmacology and Therapeutics. 2012 ; Vol. 28, No. 6. pp. 581-588.
@article{9581a6f55f3b4dceb3284516f91a4430,
title = "Evaluation of very high-and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration",
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.",
author = "Nguyen, {Quan Dong} and Campochiaro, {Peter A.} and Shah, {Syed Mahmood} and Browning, {David J.} and Hudson, {Henry L.} and Sonkin, {Peter L.} and Hariprasad, {Seenu M.} and Kaiser, {Peter K.} and Jason Slakter and Haller, {Julia A.} and Do, {Diana V} and William Mieler and Karen Chu and Avner Ingerman and Robert Vitti and Berliner, {Alyson J.} and Jesse Cedarbaum",
year = "2012",
month = "12",
day = "1",
doi = "10.1089/jop.2011.0261",
language = "English (US)",
volume = "28",
pages = "581--588",
journal = "Journal of Ocular Pharmacology and Therapeutics",
issn = "1080-7683",
publisher = "Mary Ann Liebert Inc.",
number = "6",

}

TY - JOUR

T1 - Evaluation of very high-and very low-dose intravitreal aflibercept in patients with neovascular age-related macular degeneration

AU - Nguyen, Quan Dong

AU - Campochiaro, Peter A.

AU - Shah, Syed Mahmood

AU - Browning, David J.

AU - Hudson, Henry L.

AU - Sonkin, Peter L.

AU - Hariprasad, Seenu M.

AU - Kaiser, Peter K.

AU - Slakter, Jason

AU - Haller, Julia A.

AU - Do, Diana V

AU - Mieler, William

AU - Chu, Karen

AU - Ingerman, Avner

AU - Vitti, Robert

AU - Berliner, Alyson J.

AU - Cedarbaum, Jesse

PY - 2012/12/1

Y1 - 2012/12/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84869401366&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84869401366&partnerID=8YFLogxK

U2 - 10.1089/jop.2011.0261

DO - 10.1089/jop.2011.0261

M3 - Article

VL - 28

SP - 581

EP - 588

JO - Journal of Ocular Pharmacology and Therapeutics

JF - Journal of Ocular Pharmacology and Therapeutics

SN - 1080-7683

IS - 6

ER -