NCT01796964

Efficacy and Safety Study of ESBA1008 Versus EYLEA®

A Prospective, Randomized, Double-Masked, Multicenter, Two Arm Study Comparing the Efficacy and Safety of ESBA1008 Versus EYLEA® in Subjects With Exudative Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.

Detailed description

This study consisted of 16 visits (Screening, Baseline \[Day 0\], and 14 post-baseline assessment visits) that occurred at 4-week intervals through Week 56. Enrolled subjects were randomized 1:1 to receive ESBA1008 or EYLEA. All subjects received active intravitreal (IVT) injections at baseline with 2 additional loading doses of the assigned investigational product at 4-week intervals (ie, at Weeks 4 and 8) and then received further injections at 8-weeks intervals at Weeks 16, 24, and 32. Subjects in the ESBA1008 group also received an injection at Week 44, while subjects in the EYLEA group also received injections at Weeks 40 and 48. To maintain the study masking, subjects in the ESBA1008 group received sham injections at Weeks 40 and 48 (when the subjects in the EYLEA group received active injections), while subjects in the EYLEA group received a sham injection at Week 44 (when the subjects in the ESBA1008 group received an active injection). All subjects were followed up to Week 56. Week 40 visit was the end of assessment period for the 8-week treatment cycle.

Conditions

• Exudative Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	ESBA1008 solution	For intravitreal (IVT) injection
DRUG	Aflibercept	For intravitreal (IVT) injection

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-10-01
• Completion: 2014-08-01
• First posted: 2013-02-22
• Last updated: 2016-02-09
• Results posted: 2016-02-09