Aflibercept in Polypoidal Choroidal Vasculopathy

• Status: Completed
• Trial end date: 2017-07-07
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept; Verteporfin

Criteria

Inclusion Criteria:

• Signed informed consent

• Men and women ≥50 years of age

• Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study eye established by Indocyanine Green Angiography(ICGA) at the study center

• Greatest linear dimension of the lesion of < 5400 mm (approximately, 9 Macular Photocoagulation Study disk areas), assessed by ICGA.

• An Early treatment diabetic retinopathy study (ETDRS) BCVA of 73 to 24 letters in the study eye.

Exclusion Criteria:

• Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry

• Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents in the study eye, or systemic use of anti VEGF products within 3 months prior to study entry

• Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT)

• History of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green.

• History of allergy to aflibercept, verteporfin, or their excipients.