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Recruiting Phase 4 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)

Trial Parameters

Condition Neovascular Age-related Macular Degeneration
Sponsor Genentech, Inc.
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 188
Sex ALL
Min Age 50 Years
Max Age N/A
Start Date 2021-12-14
Completion 2028-03-31
Interventions
PDS Implant With Ranibizumab 100 mg/mlLUCENTIS (Ranibizumab Injection)

Brief Summary

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

Eligibility 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 endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening * Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following: * Overall decrease in nAMD disease activity detected on hist

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