Phase 4Recruiting
A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS) (Belvedere)
A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients With Neovascular Age-related Macular Degeneration Treated With the Port Delivery System With Ranibizumab (PDS)
- Sponsor
- Genentech, Inc. (Industry)
- Enrolment
- 188 planned
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- PDS Implant With Ranibizumab 100 mg/ml; LUCENTIS (Ranibizumab Injection)
- Ages
- adults, older adults
- Registry
- NCT04853251
From the registry
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Primary outcomes
- Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the Fellow Eye, as Assessed by Specular Microscopy