Randomized, Double-masked, Sham-controlled Phase 4 Study, Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy

Sponsor
Association for Innovation and Biomedical Research on Light and Image
Study ID
NCT02495181
Phase
PHASE4
Status
Completed

Conditions

  • Polypoidal Choroidal Vasculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV).

Key Dates

Start date
Nov 23, 2015
Status verified
Feb 2019
Primary completion
Aug 22, 2017
Completion
Dec 17, 2019

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Aflibercept Monotherapy
    IVT Aflibercept 2 mg + Sham PDT
  • Active Comparator: Aflibercept + verteporfin PDT
    IVT Aflibercept 2 mg + Verteporfin PDT

Primary Outcome Measure

Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: from Baseline (Week 0) to Week 52. ]

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