Conditions: Exudative Age-Related Macular Degeneration
Keywords: Age-Related Macular Degeneration Wet Exudative AMD Intravitreal injection Retina
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 173
Healthy volunteers: no

Brief 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.

Arms:
arm 1: ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol arm 2: Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol

Interventions: intervention 1: ESBA1008 solution intervention 2: Aflibercept
Intervention descriptions: intervention 1: For intravitreal (IVT) injection intervention 2: For intravitreal (IVT) injection

Protocol document: