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

A Randomized, Double-masked, Sham-controlled Phase 4 Study of the Efficacy, Safety, and Tolerability of IV Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With PCV.

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).

To compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept associated with standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of PCV in Caucasians.

Inclusion Criteria:

• Either gender and Age ≥ 50.
• Naïve PCV patients.
• Confirmed diagnosis of symptomatic macular PCV in the study eye.
• Greatest linear dimension of the lesion of < 5400 mm, assessed by ICG angiography.
• BCVA at study entry of 25 to 80 letters (Snellen Equivalent 20/320 to 20/25).
• Lesion size in the study eye at study entry:
• Presence of PCV assessed by the Central Reading Centre based on ICG with active polyps with or without abnormal vascular network.
• Women must be using effective contraception, be post-menopausal for at least
• months prior to trial entry, or surgically sterile.
• Ability to provide written informed consent.
• Ability to return for all study visits.

Exclusion Criteria:

• Active inflammation or infection in the study eye.
• Uncontrolled intraocular pressure in the study eye.
• Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epirretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
• Presence of centromacular scarring or atrophy indicating irreversible BCVA loss.
• Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
• Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.