A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
NCT ID: NCT04049266
Last Updated: 2024-07-18
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
PHASE2/PHASE3
559 participants
INTERVENTIONAL
2019-10-08
2022-04-26
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 and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
NCT04964089
Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
NCT03790852
A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment
NCT05473715
Intravitreal Aflibercept for Submacular Hemorrhage
NCT03169660
Aflibercept Injection Into the Vitreous Body of the Eye: Study to Learn More About Patient Relevant Outcomes, Real World Treatment Patterns and How Well the Treatment Works for Patients Suffering From Abnormal Growth of New Blood Vessels Under the Retina.
NCT03714308
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 5 mg
Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol.
Drug: 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.
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 2 mg
Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks.
Drug: 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
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
* BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
Exclusion Criteria
* Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
* Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
* Active ocular or periocular infection or inflammation.
* Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
* Uncontrolled glaucoma in the Study Eye.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* Stroke or myocardial infarction in the 6-month period prior to Day 1.
* Uncontrolled blood pressure defined as a systolic value \> 180 mmHg or diastolic value ≥100 mmHg while at rest.
* 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.
50 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
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
Northwest Arkansas Retina Associates
Springdale, Arkansas, United States
California Retina Consultants
Bakersfield, California, United States
Retina Vitreous Associates
Beverly Hills, 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
Retinal Consultants Medical Group Inc
Sacramento, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
California Retina Consultants
Santa Maria, California, United States
Colorado Retina Associates PC
Lakewood, Colorado, 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
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
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
Springfield Clinic LLP
Springfield, Missouri, 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 Associates of Cleveland
Beachwood, Ohio, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cole Eye Institute
Cleveland, Ohio, United States
Retina and Vitreous Center of Southern Oregon PC
Ashland, Oregon, United States
Cascade Medical Research Institute
Eugene, Oregon, United States
Retina Northwest
Portland, Oregon, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Palmetto Retina Center
Florence, South Carolina, United States
Charleston Neuroscience Institute
Ladson, 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 Clinical Research, LLC
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, 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
Axon Clinical, s.r.o.
Prague, , Czechia
Universitätsklinikum Bonn
Bonn, , Germany
Uniklinik Köln
Cologne, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Riga Eastern Clinical University Hospital Clinic Bikernieki
Riga, , Latvia
Oftalmika Sp. z o.o.
Bydgoszcz, , Poland
Gabinet Okulistyczny prof. E. Wylegala
Katowice, , Poland
Retina Okulistyka Sp. z o.o. Sp. km.
Warsaw, , Poland
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Nemocnica Trebisov - SVET ZDRAVIA - PPDS
Trebišov, , Slovakia
Fakultna nemocnica Trencin
Trenčín, , Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, , Slovakia
Institut de La Macula i La Retina
Barcelona, , Spain
Hospital dos de Maig
Barcelona, , 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.
KSI-CL-102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.