ACTIVE_NOT_RECRUITING

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK

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Conditions

Wet Age-related Macular DegenerationWet AMDKSI-301KSI-501TarcocimabTabirafuspAfliberceptAntibody biopolymer conjugateAMDAnti-VEGFVascular endothelial growth factorKodiak Sciences

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Official Title

A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Quick Facts

Study Start:2024-08-23
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06556368

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal, and extrafoveal lesions, or retinal angiomatous proliferations (RAP) lesions with a CNV component that affects the central subfield, as evidenced by FA or OCT in the Study Eye at Screening
  2. * BCVA ETDRS score between 78 and 25 letters (Snellen equivalent \~20/32 and 20/320) inclusive, in the Study Eye at screening and reconfirmed at Day 1.
  3. * Capable of giving signed informed consent.
  1. * BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular)
  2. * Fibrosis or atrophy of \>50% of the lesion size and/or involving the foveal center of the Study Eye at Screening

Contacts and Locations

Principal Investigator

Pablo Velazquez-Martin, MD
STUDY_DIRECTOR
Kodiak Sciences Inc

Study Locations (Sites)

Associated Retina Consultants
Gilbert, Arizona, 85297
United States
Associated Retina Consultants
Phoenix, Arizona, 85020
United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
United States
Retina Associates SW
Tucson, Arizona, 85704
United States
Retina Consultants of Orange County
Fullerton, California, 92835
United States
Global Research Management, Inc. - Lugene Eye Institute
Glendale, California, 91204
United States
Retinal Consultants Medical Group, Inc.
Modesto, California, 95356
United States
California Eye Specialists Medical Group, Inc.
Pasadena, California, 91107
United States
California Eye Specialists Medical Group, Inc.
Redlands, California, 92373
United States
Retinal Consultants Medical Group Inc
Sacramento, California, 95825
United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909
United States
Retina Group of New England, PC
Waterford, Connecticut, 06385
United States
Blue Ocean Clinical Research
Clearwater, Florida, 33761
United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308
United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
United States
Retina Group of Florida
Sarasota, Florida, 34232
United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
United States
Southeast Retina Center
Augusta, Georgia, 30909
United States
Retina Associates, Ltd
Elmhurst, Illinois, 60126
United States
Illinois Retina Associates
Oak Park, Illinois, 60304
United States
Associated Vitreoretinal and Uveitis Consultants LLC
Carmel, Indiana, 46032
United States
Midwest Eye Institute
Carmel, Indiana, 46290
United States
The Retina Care Center
Baltimore, Maryland, 21209
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
United States
Retina Consultants of Minnesota
Edina, Minnesota, 55435
United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, 55416
United States
Mississippi Retina Associates
Madison, Mississippi, 39110
United States
The Retina Institute
St Louis, Missouri, 63128
United States
Retina Consultants of Nevada
Henderson, Nevada, 89052
United States
Long Island Vitreoretinal Consultants
Hauppauge, New York, 11788
United States
Retina Vitreous Surgeons of CNY PC
Liverpool, New York, 13088
United States
Retina Associates of Western NY
Rochester, New York, 14620
United States
Asheville Eye Associates
Asheville, North Carolina, 28803
United States
North Carolina Retina Associates
Cary, North Carolina, 27511
United States
Piedmont Retina Specialist
Greensboro, North Carolina, 27401
United States
Graystone Eye
Hickory, North Carolina, 28602
United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
United States
Western Carolina Clinical Research, LLC
Winston-Salem, North Carolina, 27103
United States
Retina Northwest
Portland, Oregon, 97210
United States
Cascade Medical Research Institute
Springfield, Oregon, 97477
United States
Erie Retina Research
Erie, Pennsylvania, 16507
United States
Vision Research Solutions PLLC
Philadelphia, Pennsylvania, 19141
United States
Palmetto Retina Center
Aiken, South Carolina, 29802
United States
Charleston Neuroscience Institute, LLC
Beaufort, South Carolina, 29902
United States
Charleston Neuroscience Institute, LLC
Charleston, South Carolina, 29414
United States
Charleston Neuroscience Institute, LLC
Ladson, South Carolina, 29456
United States
Charleston Neuroscience Institute
Mt. Pleasant, South Carolina, 29464
United States
Palmetto Retina Center
West Columbia, South Carolina, 29169
United States
Ophthalmology Ltd
Sioux Falls, South Dakota, 57108
United States
Charles Retina Institute
Germantown, Tennessee, 38138
United States
Retina Research Institute of Texas
Abilene, Texas, 79606
United States
Panhandle Eye Group, LLP. - Southwest Retina Specialists
Amarillo, Texas, 79106
United States
Texas Retina Associates
Arlington, Texas, 76012
United States
Austin Research Center for Retina
Austin, Texas, 78705
United States
Austin Retina Associates, PLLC
Austin, Texas, 78705
United States
Retina Consultants of Texas
Bellaire, Texas, 77401
United States
Star Vision Research
Burleson, Texas, 76028
United States
Texas Retina Associates
Fort Worth, Texas, 76104
United States
Texas Retina Center
Houston, Texas, 77030
United States
Retina Consultants of Texas
Katy, Texas, 77494
United States
Texas Retina Associates
Plano, Texas, 75075
United States
Austin Retina Associates, PLLC
Round Rock, Texas, 78681
United States
Retinal Consultants of Houston dba Retina Consultants of Texas
San Antonio, Texas, 78240
United States
Retina Consultants of Texas
Schertz, Texas, 78154
United States
Retina Consultants of Texas
The Woodlands, Texas, 77384
United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States
Pacific Northwest Retina
Bellevue, Washington, 98004
United States
Spokane Eye Clinical Research
Spokane, Washington, 99204
United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, 54403
United States

Collaborators and Investigators

Sponsor: Kodiak Sciences Inc

  • Pablo Velazquez-Martin, MD, STUDY_DIRECTOR, Kodiak Sciences Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-23
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-08-23
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • Wet AMD
  • KSI-301
  • KSI-501
  • Tarcocimab
  • Tabirafusp
  • Aflibercept
  • Antibody biopolymer conjugate
  • AMD
  • Anti-VEGF
  • Vascular endothelial growth factor
  • Kodiak Sciences

Additional Relevant MeSH Terms

  • Wet Age-related Macular Degeneration