Trials / Recruiting
RecruitingNCT04853251
A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)
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)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-12-14
- Primary completion
- 2028-03-31
- Completion
- 2028-04-30
- First posted
- 2021-04-21
- Last updated
- 2026-04-13
Locations
50 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04853251. Inclusion in this directory is not an endorsement.