Double-Masked, Randomized, Phase 2 Evaluation of Abicipar Pegol (an Anti-VEGF DARPin Therapeutic) in Neovascular Age-Related Macular Degeneration.
J Ocul Pharmacol Ther
; 34(10): 700-709, 2018 12.
Article
em En
| MEDLINE
| ID: mdl-30412448
ABSTRACT
Purpose:
To evaluate safety and efficacy of the vascular endothelial growth factor binding protein abicipar pegol (abicipar) versus ranibizumab for neovascular age-related macular degeneration.Methods:
Phase 2, multicenter, randomized, double-masked comparison (REACH study, stage 3). Patients (n = 64) received intravitreal injections of abicipar 1 mg or 2 mg at baseline, week 4, and week 8 (3 injections) or ranibizumab 0.5 mg at baseline and monthly (5 injections).Results:
In the abicipar 1 mg (n = 25), abicipar 2 mg (n = 23), and ranibizumab (n = 16) arms, respectively, least-squares mean best-corrected visual acuity (BCVA) change from baseline was +6.2, +8.3, and +5.6 letters at week 16 (primary endpoint) and +8.2, +10.0, and +5.3 letters at week 20. Least-squares mean central retinal thickness (CRT) reduction from baseline was 134, 113, and 131 µm at week 16 and 116, 103, and 138 µm at week 20. Intraocular inflammation adverse events (AEs), reported in 5/48 (10.4%) abicipar-treated patients, resolved without sustained vision loss or other sequelae.Conclusions:
Abicipar demonstrated durability of effect BCVA and CRT improvements were similar between abicipar and ranibizumab at weeks 16 and 20 (8 and 12 weeks after the last abicipar injection and 4 weeks after the last ranibizumab injection). No serious AEs were reported.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Retina
/
Proteínas Recombinantes de Fusão
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Neovascularização de Coroide
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Fator A de Crescimento do Endotélio Vascular
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Ranibizumab
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Degeneração Macular
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Aged
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Female
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Humans
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Male
Idioma:
En
Revista:
J Ocul Pharmacol Ther
Assunto da revista:
FARMACOLOGIA
/
OFTALMOLOGIA
/
TERAPEUTICA
Ano de publicação:
2018
Tipo de documento:
Article