Conditions: Neovascular Macular Degeneration
Keywords: PCV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 333
Healthy volunteers: no

Brief summary:
To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration

Detailed description:

Arms:
arm 1: Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy) arm 2: Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy)

Interventions: intervention 1: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) intervention 2: Visudyne
Intervention descriptions: intervention 1: Eylea is administered as an intravitreal injection intervention 2: Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)

Protocol document: