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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04611152
Other study ID # KS301P104
Secondary ID 2020-001062-11
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 30, 2020
Est. completion date August 31, 2023

Study information

Verified date September 2023
Source Kodiak Sciences Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.


Description:

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME. The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.


Recruitment information / eligibility

Status Terminated
Enrollment 460
Est. completion date August 31, 2023
Est. primary completion date May 11, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Signed informed consent prior to participation in the study. 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%. 7. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: 1. Macular edema in the Study Eye considered to be secondary to a cause other than DME. 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. 14. Other protocol-specified exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
KSI-301
Intravitreal Injection
Aflibercept
Intravitreal Injection
Other:
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.

Locations

Country Name City State
Germany Universitätsklinikum Freiburg Freiburg Baden-Württemberg
Germany St. Elisabeth Krankenhaus Köln Nordrhein-Westfalen
Germany St Franziskus Hospital Münster Nordrhein-Westfalen
Germany Dietrich Bonhoeffer Klinikum Neubrandenburg Neubrandenburg Mecklenburg-Vorpommern
Germany Universitätsklinikum Regensburg Regensburg Bayern
Hungary Jahn Ferenc Dél-Pesti Kórház és Rendelointézet Budapest
Hungary Ganglion Medical Center Pécs
Italy Fondazione PTV Policlinico Tor Vergata Roma
Latvia Signes Ozolinas Doctor Praxis In Ophthalmology Jelgava
Latvia Latvian American Eye Center Riga
Latvia Pauls Stradins Clinical University Hospital Riga
Latvia Riga Eastern Clinical University Hospital Clinic Bikernieki Riga
Puerto Rico Emanuelli Research & Development Center LLC Arecibo
Slovakia Fakultna nemocnica s poliklinikou Zilina Žilina
Slovakia 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
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital dos de Maig 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
United States Southwest Retina Specialists Amarillo Texas
United States Texas Retina Associates Arlington Texas
United States Austin Retina Associates Austin Texas
United States Retina Research of Beaufort Beaufort South Carolina
United States The Retina Center of New Jersey Bloomfield New Jersey
United States Retina Group of Florida Boca Raton Florida
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States Star Retina Burleson Texas
United States Charleston Neuroscience Institute - West Ashley Charleston South Carolina
United States Charlotte Eye Ear Nose & Throat Associates, P.A. Charlotte North Carolina
United States Blue Ocean Clinical Research Clearwater Florida
United States Conneticut Eye Consultants Danbury Connecticut
United States Pametto Retina Center Florence South Carolina
United States Vitreo Retinal Associates Gainesville Florida
United States Charles Retina Institute Germantown Tennessee
United States Foundation for Vision Research Grand Rapids Michigan
United States Cumberland Valley Retina Consultants PC Hagerstown Maryland
United States Retina Consultants of Texas Houston Texas
United States UCSD Jacobs Retina Center La Jolla California
United States Charleston Neuroscience Institute Ladson South Carolina
United States Florida Retina Consultants Lakeland Florida
United States Colorado Retina Associates PC Lakewood Colorado
United States Retina Associates PA Lenexa Kansas
United States Retina Associates of Kentucky Lexington Kentucky
United States Piedmont Eye Center Lynchburg Virginia
United States Florida Eye Associates Melbourne Florida
United States Tennessee Retina PC Nashville Tennessee
United States Florida Retina Institute Orlando Florida
United States Retina Specialty Institute Pensacola Florida
United States MidAtlantic Retina Philadelphia Pennsylvania
United States Retina Northwest Portland Oregon
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Retina Consultants of Southern California Redlands California
United States Retina Consultants of San Antonio San Antonio Texas
United States California Retina Consultants Santa Maria California
United States Retina Center Northwest Silverdale Washington
United States Spokane Eye Spokane Washington
United States Cascade Medical Research Institute Springfield Oregon
United States Springfield Clinic LLP Springfield Illinois
United States Retina Associates of Florida Tampa Florida
United States Retina Vitreous Associates of Florida Tampa Florida
United States NJ Retina Teaneck New Jersey
United States Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
United States Palmetto Retina Center West Columbia South Carolina
United States Wolfe Eye Clinic West Des Moines Iowa
United States Vitreo Retinal Consultants and Surgeons Wichita Kansas
United States Strategic Clinical Research Group, LLC Willow Park Texas
United States Center for Retina & Macular Disease Winter Haven Florida

Sponsors (1)

Lead Sponsor Collaborator
Kodiak Sciences Inc

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Italy,  Latvia,  Puerto Rico,  Slovakia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in BCVA to Assess Non-inferiority of KSI-301 to Aflibercept. Demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg with respect to mean change in best corrected visual acuity (BCVA). Day 1 to Year 1
Secondary Efficacy of KSI-301 5 mg compared to aflibercept 2 mg measured by changes in BCVA. Change in best corrected visual acuity (BCVA). Day 1 to Year 2
Secondary Efficacy of KSI-301 5 mg compared to aflibercept 2 mg measured by changes in CST. Change in central subfield thickness (CST). Day 1 to Year 2
Secondary Efficacy of KSI-301 5 mg compared to aflibercept 2 mg measured by changes in the diabetic retinopathy severity score (DRSS). Change in diabetic retinopathy severity score (DRSS). Day 1 to Year 2
Secondary Durability of KSI-301 5 mg compared to aflibercept 2 mg measured by number of intravitreal injections during the study. Mean number of intravitreal injections during the course of the study. Day 1 to Year 2
Secondary Safety and Tolerability of KSI-301 mg compared to aflibercept 2 mg measured by the number of ocular and systemic adverse events. Incidence of ocular and systemic adverse events. Day 1 to Year 2
See also
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