NCT01940887

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® 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 Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 645 (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 either Avastin® or Eylea® compared to Avastin® or Eylea® 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 two arms per study design: * Fovista® 1.5 mg/eye + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye * Fovista® sham + Avastin® 1.25 mg/eye or Eylea® 2 mg/eye Subjects will be treated for up to 24 months with active Fovista® or sham, in combination with either Avastin® or Eylea® with the primary endpoint at 12 months. Approximately 622 subjects will be randomized into one of the two treatment groups (311 patients per dose group), and the efficacy analysis will be based on the data from these two groups as per the SAP

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	E10030
DRUG	bevacizumab or aflibercept	Patients are randomized to receive either bevacizumab or aflibercept
DRUG	E10030 sham injection	Pressure on the eye with a syringe with no needle

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-06-01
• Completion: 2017-09-01
• First posted: 2013-09-12
• Last updated: 2024-10-31
• Results posted: 2020-09-30

Locations

207 sites across 22 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Colombia, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Norway, Poland, Portugal, Slovakia, Spain