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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04853251 on ClinicalTrials.gov