Recruiting
PHASE4
INTERVENTIONAL
NCT04853251
A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Interventions
Name:
PDS Implant With Ranibizumab 100 mg/ml
Type:
DEVICE
Description:
Ranibizumab 100 mg/mL will be delivered via PDS
Name:
LUCENTIS (Ranibizumab Injection)
Type:
DRUG
Description:
Ranibizumab (0.5 mg intravitreal \[IVT\] injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a participant discontinues study treatment, he/she may start receiving IVT ranibizumab injections in the study eye, per investigator's discretion.
Primary Outcomes
Measure:
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
TimeFrame:
Baseline, Week 48
Description:
Trial Information
NCT ID
NCT04853251
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Genentech, Inc.
Last Updated
December 15, 2025