Clinical trial NCT04964089: 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)
Official title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wet Age-related Macular Degeneration
Keywords: AMD
Wet AMD
neovascularization secondary to age-related macular degeneration
KSI-301
Aflibercept
Vascular endothelial growth factor
VEGF
Anti-VEGF
Antibody biopolymer conjugate
Macular Degeneration
wAMD
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Vision, Low
Kodiak
Lead sponsor: Kodiak Sciences Inc
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 557
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.
Primary purpose: TREATMENT

Brief summary: This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

Detailed 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 visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD)

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

Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to participation in the study.
* 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.
* Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

* BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
* 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.
* Other protocol-specified exclusion criteria may apply

Primary outcomes:
measure: Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48.
timeFrame: Day 1 to Week 48
Secondary outcomes:
measure: Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time
timeFrame: Day 1 to Week 48
measure: Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time
timeFrame: Day 1 to Week 48
measure: Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time
timeFrame: Day 1 to Week 48
measure: Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters)
timeFrame: Day 1 to Week 48
measure: Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters)
timeFrame: Day 1 to Week 48
measure: Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline to the Average of Weeks 40, 44 and 48 and Over Time
timeFrame: Day 1 to Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Springdale
country: United States
facility: Northwest Arkansas Retina Associates
state: Arkansas
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Fresno
country: United States
facility: Eye Medical Center of Fresno
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: La Jolla
country: United States
facility: UCSD Jacobs Retina Center
state: California
city: Laguna Hills
country: United States
facility: Retina Associates of Orange County
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Poway
country: United States
facility: Retina Consultants of San Diego
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group Inc
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Lakewood
country: United States
facility: Colorado Retina Associates PC
state: Colorado
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute
state: Florida
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Myers
country: United States
facility: Retina Health Center
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic LLP
state: Illinois
city: Evansville
country: United States
facility: Talley Eye
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Lenexa
country: United States
facility: Retina Associates PA
state: Kansas
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants PC
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Springfield
country: United States
facility: New England Retina Consultants
state: Massachusetts
city: Worcester
country: United States
facility: Vitreo Retinal Associates PC
state: Massachusetts
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants PC
state: Michigan
city: Edina
country: United States
facility: Vitreoretinal Surgery PA
state: Minnesota
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: The Retina Center of New Jersey
state: New Jersey
city: Teaneck
country: United States
facility: NJ Retina
state: New Jersey
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central NY
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation, Cole Eye Institute
state: Ohio
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Salem
country: United States
facility: Retina Consultants, LLC
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research Institute
state: Oregon
city: Philadelphia
country: United States
facility: MidAtlantic Retina
state: Pennsylvania
city: Beaufort
country: United States
facility: Retina Research of Beaufort
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Knoxville
country: United States
facility: Southeastern Retina Associates PC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina PC
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Texas
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas-(Katy)
state: Texas
city: Plano
country: United States
facility: Texas Retina Associates
state: Texas
city: Round Rock
country: United States
facility: Austin Retina Associates (Round Rock)
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas - (Woodlands)
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Spokane
country: United States
facility: Spokane Eye
state: Washington
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center LLC
Study officials:
affiliation: Kodiak Sciences Inc
name: Pablo Velazquez-Martin, MD
role: STUDY_DIRECTOR
References: