A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

Official title: A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination With Lucentis in Subjects With Neovascular Age-Related Macular Degeneration

Status Completed

Clinical Trial Summary

The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Clinical Trial Description

Subjects will be randomized in a 1:1:1 ratio to the following dose groups:

• E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye

• E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye

• E10030 sham + Lucentis® 0. 5 mg/eye

Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.

Primary Efficacy Endpoint:

The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24 visit

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables [visual acuity, intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein angiograms (FA), optical coherence tomography (OCT)], and laboratory variables.

Approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group). ;

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

• NCT number: NCT01089517
• Study type: Interventional
• Source: Astellas Pharma Inc
• Status: Completed
• Phase: Phase 2
• Start date: March 2010
• Completion date: June 2012