A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
NCT ID: NCT05066230
Last Updated: 2024-09-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
253 participants
INTERVENTIONAL
2021-09-07
2023-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
NCT04603937
Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
NCT05383209
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
NCT04592419
A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
NCT04611152
Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema
NCT06825702
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary endpoint will be assessed at Week 48; additional secondary endpoints for efficacy will be assessed at Week 48, Week 96 and if applicable, over time.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
KSI-301 - Treatment Group A
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
KSI-301
Intravitreal injection
Treatment Group B
Sham injection on the same schedule as Treatment Group A
Sham injection
The sham injection 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 is performed to maintain masking of the study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
KSI-301
Intravitreal injection
Sham injection
The sham injection 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 is performed to maintain masking of the study.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Type 1 or 2 diabetes mellitus
* Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 as determined by the reading center), in which pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
* BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
* HbA1c of ≤12%.
Exclusion Criteria
* Prior PRP in the Study Eye.
* Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
* Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME.
* Prior intravitreal or periocular steroid in the Study Eye for DR or DME.
* Prior use of an investigational intravitreal treatment for DR or DME 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 alter visual acuity during the study
* Active or suspected ocular or periocular infection or inflammation.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* 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.
* 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.
* Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥ 100 mmHg while at rest.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kodiak Sciences Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pablo Velazquez-Martin, MD
Role: STUDY_DIRECTOR
Kodiak Sciences Inc
Daniel Janer, MD
Role: STUDY_DIRECTOR
Kodiak Sciences Inc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Retinal Research Institute, LLC
Phoenix, Arizona, United States
Retina Vitreous Associates
Beverly Hills, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
California Retina Consultants - Santa Maria
Santa Maria, California, United States
Connecticut Eye Consultants
Danbury, Connecticut, United States
Retina Group of New England
Waterford, Connecticut, United States
The Macula Center/ Blue Ocean Clinical Research
Clearwater, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Med Eye Associates
Miami, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Center for Retina & Macular Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Retina Specialists of Idaho
Boise, Idaho, United States
University of Chicago
Chicago, Illinois, United States
Springfield Clinic LLP
Springfield, Illinois, United States
Retina Associates PA
Lenexa, Kansas, United States
Cumberland Valley Retina Consultants PC
Hagerstown, Maryland, United States
Foundation for Vision Research
Grand Rapids, Michigan, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular LLC
Bloomfield, New Jersey, United States
Long Island Vitreoretinal Consultants
Hauppauge, New York, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, United States
Graystone Eye
Hickory, North Carolina, United States
Cascade Medical Research Institute
Eugene, Oregon, United States
MidAtlantic Retina
Bethlehem, Pennsylvania, United States
Charleston Neurosciences Institute
Beaufort, South Carolina, United States
Charleston Neuroscience Center
Charleston, South Carolina, United States
Southeastern Retina Associates PC
Knoxville, Tennessee, United States
Charles Retina Institute
Memphis, Tennessee, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Panhandle Eye Group, LLP
Amarillo, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas (Houston)
Bellaire, Texas, United States
Star Vision Consultants
Burleson, 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 San Antonio
San Antonio, Texas, United States
Retina Consultants of Texas - (Woodlands)
The Woodlands, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Spokane Eye
Spokane, Washington, United States
OFTEX s.r.o.
Pardubice, Pardubický kraj, Czechia
Axon Clinical, s.r.o.
Prague, , Czechia
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Latvian American Eye Center
Riga, , Latvia
Warszawski Szpital Okulistyczny
Warsaw, Masovian Voivodeship, Poland
Optimum Profesorskie Centrum Okulistyki
Gdansk, Pomeranian Voivodeship, Poland
Oftalmika Sp. z o.o.
Bydgoszcz, , Poland
Emanuelli Research & Development Center LLC
Arecibo, , Puerto Rico
Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica, , Slovakia
Fakultna nemocnica Trencin
Trenčín, , Slovakia
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari General de Catalunya - Grupo Quironsalud
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, Majadanonda, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KS301P106
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.