Overview

Japanese Treat and Extend Study of Aflibercept in Neovascular Age-related Macular Degeneration

Status:
Completed
Trial end date:
2017-12-20
Target enrollment:
0
Participant gender:
All
Summary
To assess the efficacy of intravitreal (IVT) administration of aflibercept with two different approaches of Treat and Extend dosing regimens in Japanese subjects with neovascular (wet) Age-related Macular Degeneration (wAMD) . To assess the safety of IVT administration of aflibercept with two different approaches of Treat and Extend dosing regimen in Japanese subjects with wAMD for up to 2 years.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Collaborator:
Regeneron Pharmaceuticals
Treatments:
Aflibercept
Criteria
Inclusion Criteria:

- Japanese men and women ≥ 50 years of age

- Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD,
including juxta-foveal lesions that affect the fovea as evidenced by fluorescein
angiography (FA) in the study eye

- Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA)
of 73 to 25 letters (approximately 20/40 to 20/320 at Snellen equivalent) in the study
eye

Exclusion Criteria:

- Prior treatment of the study eye with intraocular anti-VEGF(Vascular Endothelial
Growth Factor) agents, verteporfin photodynamic therapy (PDT), other laser,
intraocular corticosteroids, surgical interventions (except cataract surgery more than
30 days prior to screening) or systemic use of anti-VEGF products within 3 months
prior to study entry

- Active or suspected infection in or surrounding of the study eye

- Active severe intraocular inflammation in the study eye

- Intraocular pressure (IOP) ≥ 25 mmHg in the study eye

- Ocular condition in the study eye which may impact vision and confound study outcomes