Clinical trial NCT04049266: 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.
Official title: A Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Wet Macular Degeneration
Keywords: AMD
Wet AMD
choroidal neovascularization secondary to age-related macular degeneration
KSI-301
Aflibercept
Vascular endothelial growth factor
VEGF
Anti-VEGF
Antibody biopolymer conjugate
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Vision, low
Kodiak
Lead sponsor: Kodiak Sciences Inc
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 559
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).

Detailed description: This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* CNV secondary to other causes in the Study Eye.
* 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.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1
timeFrame: Year 1
Secondary outcomes:
measure: Percentage of Subjects on KSI-301 Arm With a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval
timeFrame: Year 1
measure: Percentage of Subjects Gaining ≥ 5, ≥10 and ≥15 Letters in BCVA From Baseline in the Study Eye, Full Analysis Set Year 1
timeFrame: Year 1
measure: Percentage of Subjects Who Achieving BCVA Snellen Equivalent of 20/40 or Better in the Study Eye at Year 1
timeFrame: Year 1
measure: Percentage of Subjects With BCVA Snellen Equivalent of 20/200 or Worse in the Study Eye at Year 1
timeFrame: Year 1
measure: Mean Change in OCT Central Subfield Retinal Thickness (CST) From Day 1
timeFrame: Year 1
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: Beverly Hills
country: United States
facility: Retina Vitreous Associates
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: 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: Santa Maria
country: United States
facility: California Retina Consultants
state: California
city: Lakewood
country: United States
facility: Colorado Retina Associates PC
state: Colorado
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: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Lenexa
country: United States
facility: Retina Associates PA
state: Kansas
city: Wichita
country: United States
facility: Vitreo Retinal Consultants and Surgeons
state: Kansas
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants PC
state: Maryland
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: Springfield
country: United States
facility: Springfield Clinic LLP
state: Missouri
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: Beachwood
country: United States
facility: Retina Associates of Cleveland
state: Ohio
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: Ashland
country: United States
facility: Retina and Vitreous Center of Southern Oregon PC
state: Oregon
city: Eugene
country: United States
facility: Cascade Medical Research Institute
state: Oregon
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Florence
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
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 Clinical Research, LLC
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Bellaire
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: Praha
country: Czechia
facility: Axon Clinical, s.r.o.
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Köln
country: Germany
facility: Uniklinik Köln
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga Eastern Clinical University Hospital Clinic Bikernieki
city: Bydgoszcz
country: Poland
facility: Oftalmika Sp. z o.o.
city: Katowice
country: Poland
facility: Gabinet Okulistyczny prof. E. Wylegala
city: Warszawa
country: Poland
facility: Retina Okulistyka Sp. z o.o. Sp. km.
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Trebišov
country: Slovakia
facility: Nemocnica Trebisov - SVET ZDRAVIA - PPDS
city: Trenčín
country: Slovakia
facility: Fakultna nemocnica Trencin
city: Žilina
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Zilina
city: Barcelona
country: Spain
facility: Institut de La Macula i La Retina
city: Barcelona
country: Spain
facility: Hospital dos de Maig
Study officials:
affiliation: Kodiak Sciences Inc
name: Pablo Velazquez-Martin, MD
role: STUDY_DIRECTOR
References: