A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
NCT ID: NCT04611152
Last Updated: 2024-08-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
460 participants
INTERVENTIONAL
2020-09-30
2023-08-31
Brief Summary
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Detailed Description
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The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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KSI-301 (Arm A)
Intravitreal injection of KSI-301 (5 mg) once every 4 weeks for 3 monthly doses followed by an individualized dosing regimen (every 8 to 24 weeks) via intravitreal injection from Week 16 to Week 100.
KSI-301
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.
Aflibercept (Arm B)
Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 5 monthly doses followed by aflibercept (2 mg) once every 8 weeks via intravitreal injection from Week 24 to 100.
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
2. Treatment-naïve diabetic macular edema, with vision loss and center involvement (if present) diagnosed within 9 months of screening.
3. BCVA ETDRS letter score between 78 and 25 (-20/25 to 20/320 Snellen equivalent), inclusive, in the Study Eye.
4. CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center.
5. Decrease in vision determined by the Investigator to be primarily the result of DME.
6. Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%.
Exclusion Criteria
2. Active iris or angle neovascularization or neovascular glaucoma in the Study Eye.
3. High-risk proliferative diabetic retinopathy characteristics in the Study Eye.
4. History of Pan-retinal Photocoagulation (PRP) laser in the Study Eye within 3 months of screening.
5. Tractional retinal detachment in the Study Eye.
6. Active retinal disease other than the condition under investigation in the Study Eye.
7. Any history or evidence of a concurrent ocular condition present, 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 (e.g., vitreomacular traction, epiretinal membrane).
8. Active or suspected ocular or periocular infection or inflammation in either eye at Day 1.
9. Any prior use of an approved or investigational treatment for DME in the Study Eye (e.g., anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
10. Women who are pregnant or lactating or intending to become pregnant during the study.
11. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest.
12. 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.
13. 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.
18 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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UCSD Jacobs Retina Center
La Jolla, California, United States
Retina Consultants of Southern California
Redlands, California, United States
California Retina Consultants
Santa Maria, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Colorado Retina Associates PC
Lakewood, Colorado, United States
Conneticut Eye Consultants
Danbury, Connecticut, United States
Retina Group of Florida
Boca Raton, Florida, United States
Blue Ocean Clinical Research
Clearwater, Florida, United States
Vitreo Retinal Associates
Gainesville, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Associates of Florida
Tampa, Florida, United States
Retina Vitreous Associates of Florida
Tampa, Florida, United States
Center for Retina & Macular Disease
Winter Haven, Florida, United States
Springfield Clinic LLP
Springfield, Illinois, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Retina Associates PA
Lenexa, Kansas, United States
Vitreo Retinal Consultants and Surgeons
Wichita, Kansas, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
Cumberland Valley Retina Consultants PC
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Foundation for Vision Research
Grand Rapids, Michigan, United States
The Retina Center of New Jersey
Bloomfield, New Jersey, United States
NJ Retina
Teaneck, New Jersey, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Charlotte, North Carolina, United States
Retina Northwest
Portland, 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 - West Ashley
Charleston, South Carolina, United States
Pametto Retina Center
Florence, 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
Charles Retina Institute
Germantown, Tennessee, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Southwest Retina Specialists
Amarillo, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Star Retina
Burleson, Texas, United States
Retina Consultants of Texas
Houston, Texas, United States
Retina Consultants of San Antonio
San Antonio, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Retina Center Northwest
Silverdale, Washington, United States
Spokane Eye
Spokane, Washington, United States
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany
Dietrich Bonhoeffer Klinikum Neubrandenburg
Neubrandenburg, Mecklenburg-Vorpommern, Germany
St. Elisabeth Krankenhaus
Cologne, North Rhine-Westphalia, Germany
St Franziskus Hospital
Münster, North Rhine-Westphalia, Germany
Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
Budapest, , Hungary
Ganglion Medical Center
Pécs, , Hungary
Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
Signes Ozolinas Doctor Praxis In Ophthalmology
Jelgava, , Latvia
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Riga Eastern Clinical University Hospital Clinic Bikernieki
Riga, , Latvia
Latvian American Eye Center
Riga, , Latvia
Emanuelli Research & Development Center LLC
Arecibo, , Puerto Rico
Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica, , Slovakia
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Uvea Klinika, S.R.O.
Martin, , Slovakia
Nemocnica s poliklinikou Trebisov a.s. Ocne oddelenie - jednonova zdravotna starostlivost
Trebišov, , Slovakia
Fakultna nemocnica Trencin
Trencín, , Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, , Slovakia
Hospital dos de Maig
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari General de Catalunya - Grupo Quironsalud
Barcelona, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital Universitario Rio Hortega
Valladolid, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
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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2020-001062-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KS301P104
Identifier Type: -
Identifier Source: org_study_id
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