NCT01089517

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Ophthotech Corporation · Industry
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	E10030 plus Lucentis	once a month intravitreal injection
DRUG	Lucentis	10 mg/mL intravitreal injection monthly

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-03-18
• Last updated: 2024-03-19
• Results posted: 2014-01-03

Locations

1 site across 1 country: United States