NCT01944839

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Ophthotech Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Detailed description

Subjects will be randomized in a 1:1 ratio to the following dose groups: * Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye * Fovista® sham + Lucentis® 0.5 mg/eye Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months. Primary Efficacy Endpoint: The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit. Safety Endpoints: Safety endpoints include adverse events, vital signs, ophthalmic variables \[ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)\], ECG, and laboratory variables. Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	E10030
DRUG	ranibizumab
DRUG	E10030 sham intravitreal injection	Pressure on the eye with a syringe with no needle

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-09-18
• Last updated: 2024-10-30
• Results posted: 2018-08-10

Locations

115 sites across 13 countries: United States, Austria, Belgium, Brazil, Canada, Czechia, Estonia, Italy, Latvia, Poland, Slovakia, Switzerland, United Kingdom