A Prospective, Observational, Post-Marketing Surveillance Study to Monitor the Safety of the Port Delivery System with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration (VILLA)
- Sponsor: Genentech, Inc.
- Principal Investigator: Michael Altaweel, MD
- Study Coordinator: Kris Dietzman
Study objective:
To evaluate safety and tolerability of the Port Delivery System (PDS) in patients with neovascular age-related macular degeneration (nAMD).
Study design:
Patients planned to receive a PDS implant for treatment of nAMD will be followed for a fixed period of 3 years after initial implantation. This is a prospective, single-arm, observational study.
Inclusion criteria:
- Diagnosis of nAMD
- Clinical decision has been made for the treatment with the PDS
Exclusion criteria:
- Active participation in any other clinical trial for nAMD
- Active participation in any other medical or surgical interventional ophthalmology clinical trial
- Patients who have already received PDS treatment before study entry