RecruitingPhase 4NCT04853251

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)

Sponsor

Genentech, Inc.

Enrollment

188 participants

Start Date

Dec 14, 2021

Study Type

INTERVENTIONAL

Conditions

Neovascular Age-related Macular Degeneration

Summary

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

Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the effect of the Port Delivery System with Ranibizumab (PDS) — a small implant placed in the eye that continuously releases the anti-VEGF drug ranibizumab to treat wet age-related macular degeneration (nAMD) — on corneal endothelial cells, the fragile inner lining of the cornea. These cells are critical for keeping the cornea clear, and they cannot regenerate. Preserving corneal health is essential for long-term vision. Patients with wet AMD who are receiving the PDS implant will undergo regular specular microscopy (a non-invasive test that counts and images corneal cells) over two years to track whether the implant affects corneal cell density. You may be eligible if: - You are 50 years or older - You have wet age-related macular degeneration (nAMD) - Your vision is 20/200 or better in the study eye - You have responded to at least two prior anti-VEGF injections - Your corneal cell counts are adequate (above 1500 cells/mm²) - You have given consent and can attend all study visits You may NOT be eligible if: - You have had prior eye surgery (including cataract) within 6 months - You have had a corneal transplant - You have a history of significant eye inflammation or infection - You have active cancer, severe systemic disease, or recent stroke or heart attack - You are pregnant or breastfeeding - You have a history of Fuchs endothelial dystrophy grade 2 or higher Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPDS Implant With Ranibizumab 100 mg/ml

Ranibizumab 100 mg/mL will be delivered via PDS

DRUGLUCENTIS (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(50)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

Retina Associates of Southern California

Huntington Beach, California, United States

California Eye Specialists Medical group Inc.

Pasadena, California, United States

Retinal Consultants Med Group

Sacramento, California, United States

University of California San Francisco

San Francisco, California, United States

Orange County Retina Med Group

Santa Ana, California, United States

Macula Retina Vitreous Research Institute

Torrance, California, United States

Southwest Retina Consultants

Durango, Colorado, United States

Advanced Vision Research Institute

Longmont, Colorado, United States

Retina Group of New England

Waterford, Connecticut, United States

Retina Specialty Institute

Pensacola, Florida, United States

Ft Lauderdale Eye Institute

Plantation, Florida, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Southeast Retina Center

Augusta, Georgia, United States

University Retina and Macula Associates, PC

Lemont, Illinois, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Retina Associates of Kentucky

Lexington, Kentucky, United States

Maine Eye Center

Portland, Maine, United States

The Retina Care Center

Baltimore, Maryland, United States

Wilmer Eye Institute Johns Hopkins University

Baltimore, Maryland, United States

Retina Group of Washington

Chevy Chase, Maryland, United States

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, United States

Associated Retinal Consultants PC

Royal Oak, Michigan, United States

VitreoRetinal Surgery, PLLC.

Minneapolis, Minnesota, United States

Midwest Vision Research Foundation

Chesterfield, Missouri, United States

Sierra Eye Associates

Reno, Nevada, United States

Envision Ocular, LLC

Bloomfield, New Jersey, United States

Seeta Eye Centers

Poughkeepsie, New York, United States

Western Carolina Retinal Associate PA

Asheville, North Carolina, United States

Duke Eye Center

Durham, North Carolina, United States

Fargo Retina Consultants

Fargo, North Dakota, United States

Cincinnati Eye Institute

Blue Ash, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Tulsa Retina Consultants

Tulsa, Oklahoma, United States

Erie Retina Research

Erie, Pennsylvania, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Palmetto Retina Center

Florence, South Carolina, United States

Palmetto Retina Center, LLC

West Columbia, South Carolina, United States

Charles Retina Institute

Germantown, Tennessee, United States

Tennessee Retina PC

Nashville, Tennessee, United States

Panhandle Eye Group LLP Southwest Retina Specialists

Amarillo, Texas, United States

Austin Retina Associates

Austin, Texas, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Retina Consultants of Texas

Schertz, Texas, United States

Retina Associates of Utah, PLLC

Salt Lake City, Utah, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Wagner Kapoor Institute

Norfolk, Virginia, United States

Retina Institute of Virginia

Richmond, Virginia, United States

Spokane Eye Clinical Research

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04853251

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