Conditions: Exudative Age-Related Macular Degeneration
Keywords: Exudative Age-Related Macular Degeneration Wet AMD Choroidal neovascularization (CNV) Vascular endothelial growth factor (VEGF)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a microvolume injection or infusion on retinal function and morphology in subjects with exudative age-related macular degeneration (AMD).

Detailed description:
This 4-cohort study was conducted in 2 stages. Stage 1 consisted out of 2 Cohorts. In each cohort subjects were randomized 10:3 to either receive ESBA1008 (Cohort 1 : 2 injections, Cohort 2 : 1 infusion and 1 injection) or 2 Lucentis injections. Stage 2 was conducted similarly with a different dosing level for ESBA1008 (Cohort 3 and 4). Subjects had follow-up visits at Day 7 and Day 14. All cohorts receiving ESBA1008 on Day 0 also received ESBA1008 6mg/50 μL via injection on Day 28. After the Day 28 visit (all cohorts), subjects returned for follow up visits at Day 42 and Day 56.

Arms:
arm 1: Cohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28 arm 2: Cohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 arm 3: Cohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 arm 4: Cohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28 arm 5: Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28

Interventions: intervention 1: ESBA1008 solution intervention 2: Ranibizumab
Intervention descriptions: intervention 1: Intravitreal injection or infusion intervention 2: Intravitreal injection

Protocol document: