Dual Antagonism of PDGF and VEGF in Neovascular Age-Related Macular Degeneration: A Phase IIb, Multicenter, Randomized Controlled Trial.

Détails

ID Serval
serval:BIB_D23797EF9B3F
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Titre
Dual Antagonism of PDGF and VEGF in Neovascular Age-Related Macular Degeneration: A Phase IIb, Multicenter, Randomized Controlled Trial.
Périodique
Ophthalmology
Auteur(s)
Jaffe G.J., Ciulla T.A., Ciardella A.P., Devin F., Dugel P.U., Eandi C.M., Masonson H., Monés J., Pearlman J.A., Quaranta-El Maftouhi M., Ricci F., Westby K., Patel S.C.
ISSN
1549-4713 (Electronic)
ISSN-L
0161-6420
Statut éditorial
Publié
Date de publication
02/2017
Peer-reviewed
Oui
Volume
124
Numéro
2
Pages
224-234
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
To assess the safety and efficacy of E10030 (Fovista; Ophthotech, New York, NY), a platelet-derived growth factor (PDGF) antagonist, administered in combination with the anti-vascular endothelial growth factor (VEGF) agent ranibizumab (Lucentis; Roche, Basel, Switzerland) compared with ranibizumab monotherapy in patients with neovascular age-related macular degeneration (nAMD).
Phase IIb global, multicenter, randomized, prospective, double-masked, controlled superiority trial.
Four hundred forty-nine patients with treatment-naïve nAMD.
Participants were randomized in a 1:1:1 ratio to 1 of the following 3 intravitreal treatment groups: E10030 0.3 mg in combination with ranibizumab 0.5 mg, E10030 1.5 mg in combination with ranibizumab 0.5 mg, and sham in combination with ranibizumab 0.5 mg (anti-VEGF monotherapy). Drugs were administered monthly in each of the groups for a total duration of 24 weeks.
The prespecified primary end point was the mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy [ETDRS] letters) from baseline to 24 weeks.
No significant safety issues were observed in any treatment group. The E10030 (1.5 mg) combination therapy regimen met the prespecified primary end point of superiority in mean VA gain compared with anti-VEGF monotherapy (10.6 compared with 6.5 ETDRS letters at week 24; P = 0.019). A dose-response relationship was evident at each measured time point commencing at 4 weeks. Visual acuity outcomes favored the E10030 1.5 mg combination therapy group regardless of baseline VA, lesion size, or central subfield thickness on optical coherence tomography. All clinically relevant treatment end points of visual benefit (≥15 ETDRS letter gain, final VA ≥20/40 or ≥20/25) and visual loss (≥1 ETDRS line loss, ≥2 ETDRS line loss, final VA ≤20/125 or ≤20/200) favored the E10030 1.5 mg combination group.
In this phase IIb clinical trial, a 62% relative benefit from baseline was noted in the E10030 1.5 mg combination therapy group compared with the anti-VEGF monotherapy group. A favorable safety and efficacy profile of E10030 combination therapy for nAMD was evident across multiple clinically relevant end points. This highly powered study provides strong rationale for a confirmatory phase III clinical trial.
Mots-clé
Aged, Aged, 80 and over, Angiogenesis Inhibitors/therapeutic use, Aptamers, Nucleotide/antagonists & inhibitors, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Intravitreal Injections, Male, Middle Aged, Platelet-Derived Growth Factor/antagonists & inhibitors, Prospective Studies, Ranibizumab/therapeutic use, Vascular Endothelial Growth Factor A/antagonists & inhibitors, Visual Acuity, Wet Macular Degeneration/drug therapy
Pubmed
Web of science
Open Access
Oui
Création de la notice
12/03/2021 19:20
Dernière modification de la notice
26/03/2021 7:35
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