Aflibercept in Polypoidal Choroidal Vasculopathy

Conditions

• Neovascular Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) — DRUG
  Eylea is administered as an intravitreal injection
• Visudyne — OTHER
  Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)

Study Details

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

Key Dates

Start date

May 29, 2014

Status verified

Nov 2020

Primary completion

Aug 12, 2016

Completion

Jul 7, 2017

Study Design

Enrollment

333 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Aflibercept + Sham PDT
  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)
• Experimental: Aflibercept + Active PDT
  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)

Primary Outcome Measure

Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: From Baseline to Week 52 ]