A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
NCT ID: NCT04964089
Last Updated: 2024-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
557 participants
INTERVENTIONAL
2021-06-23
2023-04-06
Brief Summary
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Detailed Description
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The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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KSI-301 (Treatment Group A)
Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.
KSI-301
Intravitreal Injection
Aflibercept (Treatment Group B)
Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.
Aflibercept
Intravitreal Injection
Sham Procedure
The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Interventions
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KSI-301
Intravitreal Injection
Aflibercept
Intravitreal Injection
Sham Procedure
The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
* BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.
* Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
Exclusion Criteria
* Active or suspected ocular or periocular infection or inflammation.
* CNV secondary to other causes in the Study Eye.
* Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study.
* Uncontrolled glaucoma in the Study Eye.
* Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
* Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
* History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
* Uncontrolled blood pressure defined as a systolic value ≥180 mmHg or diastolic value ≥100 mmHg while at rest.
50 Years
ALL
No
Sponsors
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Kodiak Sciences Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Pablo Velazquez-Martin, MD
Role: STUDY_DIRECTOR
Kodiak Sciences Inc
Locations
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Retinal Research Institute, LLC
Phoenix, Arizona, United States
Northwest Arkansas Retina Associates
Springdale, Arkansas, United States
California Retina Consultants
Bakersfield, California, United States
Eye Medical Center of Fresno
Fresno, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
UCSD Jacobs Retina Center
La Jolla, California, United States
Retina Associates of Orange County
Laguna Hills, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Retina Consultants of San Diego
Poway, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
Colorado Retina Associates PC
Lakewood, Colorado, United States
Retina Group of New England
Waterford, Connecticut, United States
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Retina Health Center
Fort Myers, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Retina Associates of Florida
Tampa, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Springfield Clinic LLP
Springfield, Illinois, United States
Talley Eye
Evansville, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Retina Associates PA
Lenexa, Kansas, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants PC
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
New England Retina Consultants
Springfield, Massachusetts, United States
Vitreo Retinal Associates PC
Worcester, Massachusetts, United States
Foundation for Vision Research
Grand Rapids, Michigan, United States
Associated Retinal Consultants PC
Royal Oak, Michigan, United States
Vitreoretinal Surgery PA
Edina, Minnesota, United States
Sierra Eye Associates
Reno, Nevada, United States
The Retina Center of New Jersey
Bloomfield, New Jersey, United States
NJ Retina
Teaneck, New Jersey, United States
Retina-Vitreous Surgeons of Central NY
Liverpool, New York, United States
Retina Associates of Western NY
Rochester, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cole Eye Institute
Cleveland, Ohio, United States
Retina Northwest
Portland, Oregon, United States
Retina Consultants, LLC
Salem, Oregon, United States
Cascade Medical Research Institute
Springfield, Oregon, United States
MidAtlantic Retina
Philadelphia, Pennsylvania, United States
Retina Research of Beaufort
Beaufort, South Carolina, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Southeastern Retina Associates PC
Knoxville, Tennessee, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Houston, Texas, United States
Retina Consultants of Texas-(Katy)
Katy, Texas, United States
Texas Retina Associates
Plano, Texas, United States
Austin Retina Associates (Round Rock)
Round Rock, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Consultants of Texas - (Woodlands)
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Spokane Eye
Spokane, Washington, United States
Emanuelli Research & Development Center LLC
Arecibo, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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KS301P107
Identifier Type: -
Identifier Source: org_study_id
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