Conditions: Exudative Age-Related Macular Degeneration
Keywords: Wet AMD Intravitreal Injection Macular Degeneration VEGF treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
The primary purpose of this study was to demonstrate a biological effect of AL-78898A, as measured by change (reduction) in central subfield (CSF) retinal thickness 4 weeks after a single intravitreal injection, as compared to LUCENTIS.

Detailed description:
The study consisted of a Screening Visit (Visit 1), a Day 0 visit (Visit 2), 6 on-therapy visits at Day 1, Weeks 1, 2, 3, 4, and 8 (Visits 3-8), and an Exit Visit at Week 12 (Visit 9). Patients who met all inclusion and exclusion criteria at Visit 1 were randomized in a 3:1 ratio to receive either AL-78898A or LUCENTIS as a single 50-μL injection in the study eye. Additionally, patients received standard therapy for exudative AMD beginning at Week 2/Visit 5 if the patient was not improving per protocol-specified criteria. Beginning at Week 4/Visit 7, patients not improving received standard therapy for exudative AMD at the investigator's discretion.

Arms:
arm 1: Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up arm 2: Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up

Interventions: intervention 1: AL-78898A intervention 2: Ranibizumab
Intervention descriptions: intervention 1: Investigational treatment intervention 2: Anti-vascular endothelial growth factor (VEGF) treatment

Protocol document: