A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
NCT04853251 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188
Last updated 2026-05-12
Summary
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Conditions
- Neovascular Age-related Macular Degeneration
Interventions
- DEVICE
-
PDS Implant With Ranibizumab 100 mg/ml
Ranibizumab 100 mg/mL will be delivered via PDS
- DRUG
-
LUCENTIS (Ranibizumab Injection)
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.
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Genentech, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-14
- Primary Completion
- 2027-09-30
- Completion
- 2027-10-29
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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