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)

Who is this study for? Patients with neovascular age-related macular degeneration previously treated with intravitreal agents other than ranibizumab
What treatments are being studied? Susvimo+Lucentis
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

∙ 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 historical or screening OCT

⁃ Stable or improved best-corrected visual acuity (BCVA)

• BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment

• All subtypes of nAMD lesions are permissible

• nAMD lesions at the time of diagnosis must involve the macula

• Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images

Locations
United States
Arizona
Barnet Dulaney Perkins Eye Center
RECRUITING
Mesa
California
California Retina Consultants
RECRUITING
Bakersfield
Retina Associates of Southern California
RECRUITING
Huntington Beach
California Eye Specialists Medical group Inc.
RECRUITING
Pasadena
Retinal Consultants Med Group
RECRUITING
Sacramento
University of California San Francisco
RECRUITING
San Francisco
Orange County Retina Med Group
RECRUITING
Santa Ana
Macula Retina Vitreous Research Institute
RECRUITING
Torrance
Colorado
Southwest Retina Consultants
COMPLETED
Durango
Advanced Vision Research Institute
RECRUITING
Longmont
Connecticut
Retina Group of New England
WITHDRAWN
Waterford
Florida
Retina Specialty Institute
RECRUITING
Pensacola
Ft Lauderdale Eye Institute
WITHDRAWN
Plantation
Retina Vitreous Associates of Florida
RECRUITING
St. Petersburg
Georgia
Southeast Retina Center
RECRUITING
Augusta
Iowa
Wolfe Eye Clinic
WITHDRAWN
West Des Moines
Illinois
University Retina and Macula Associates, PC
RECRUITING
Lemont
Kentucky
Retina Associates of Kentucky
WITHDRAWN
Lexington
Maryland
The Retina Care Center
RECRUITING
Baltimore
Wilmer Eye Institute Johns Hopkins University
RECRUITING
Baltimore
Retina Group of Washington
WITHDRAWN
Chevy Chase
Cumberland Valley Retina Consultants PC
RECRUITING
Hagerstown
Maine
Maine Eye Center
RECRUITING
Portland
Michigan
Associated Retinal Consultants PC
RECRUITING
Royal Oak
Minnesota
VitreoRetinal Surgery, PLLC.
RECRUITING
Minneapolis
Missouri
Midwest Vision Research Foundation
COMPLETED
Chesterfield
North Carolina
Western Carolina Retinal Associate PA
WITHDRAWN
Asheville
Duke Eye Center
RECRUITING
Durham
North Dakota
Fargo Retina Consultants
RECRUITING
Fargo
New Jersey
Envision Ocular, LLC
RECRUITING
Bloomfield
Nevada
Sierra Eye Associates
RECRUITING
Reno
New York
Seeta Eye Centers
RECRUITING
Poughkeepsie
Ohio
Cincinnati Eye Institute
RECRUITING
Blue Ash
Cleveland Clinic Foundation
RECRUITING
Cleveland
Oklahoma
Tulsa Retina Consultants
RECRUITING
Tulsa
Pennsylvania
Erie Retina Research
RECRUITING
Erie
Mid Atlantic Retina
WITHDRAWN
Philadelphia
South Carolina
Palmetto Retina Center
WITHDRAWN
Florence
Palmetto Retina Center, LLC
WITHDRAWN
West Columbia
Tennessee
Charles Retina Institute
RECRUITING
Germantown
Tennessee Retina PC
RECRUITING
Nashville
Texas
Panhandle Eye Group LLP Southwest Retina Specialists
RECRUITING
Amarillo
Austin Retina Associates
WITHDRAWN
Austin
Retina Consultants of Texas
RECRUITING
Bellaire
Retina Consultants of Texas
RECRUITING
Schertz
Utah
Retina Associates of Utah, PLLC
RECRUITING
Salt Lake City
Virginia
Piedmont Eye Center
RECRUITING
Lynchburg
Wagner Kapoor Institute
RECRUITING
Norfolk
Retina Institute of Virginia
WITHDRAWN
Richmond
Washington
Spokane Eye Clinical Research
RECRUITING
Spokane
Contact Information
Primary
Reference Study ID Number: ML43000 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Time Frame
Start Date: 2021-12-14
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 188
Treatments
Experimental: SUSVIMO
Participants will have the PDS implant (filled prior to implantation with approximately 20 microlitres \[uL\] of the 100 milligrams/millilitres \[mg/ml\] formulation of ranibizumab \[approximately 2 milligrams (mg) dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their enrollment visit. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed Q24W intervals.
Sponsors
Leads: Genentech, Inc.

This content was sourced from clinicaltrials.gov