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)

Genentech, Inc.

Summary

This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

Eligibility

Age range: 50+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria Ocular Inclusion Criteria: * Diagnosis of nAMD prior to screening as determined by the investigator * Difference of \<10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center * Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion * Availability of comprehensive historical anti-vascular endothe…

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.

Locations (52)

Barnet Dulaney Perkins Eye Center
Mesa, Arizona
California Retina Consultants
Bakersfield, California
Retina Associates of Southern California
Huntington Beach, California
California Eye Specialists Medical group Inc.
Pasadena, California
Retinal Consultants Med Group
Sacramento, California
University of California San Francisco
San Francisco, California