Clinical trial NCT05066230: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
Official title: A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm Phase3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-proliferative Diabetic Retinopathy
Keywords: Non-proliferative Diabetic Retinopathy
Diabetic Retinopathy
NPDR
KSI-301
VEGF
Anti-VEGF
Vascular Endothelial Growth Factor
Antibody Biopolymer Conjugate
Retinal Degeneration
Retinal Diseases
Eye Diseases
Retinopathy
Vision Disorders
Kodiak
Lead sponsor: Kodiak Sciences Inc
Sponsor class: INDUSTRY
First posted: 2021-10-04
Enrollment: 253
Sex: ALL
Minimum age (years): 18
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 arms: KSI-301 or sham.
Primary purpose: TREATMENT

Brief summary: This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Detailed description: This is a Phase 3, prospective, randomized, double-masked, sham-controlled, two-arm, multicenter study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Presence of center-involved DME in the Study Eye
* 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.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Patients Improving ≥2 Steps on DRSS
timeFrame: Day 1 to Week 48
Secondary outcomes:
measure: Percentage of Patients Developing Any Sight-Threatening Complication
timeFrame: Day 1 to Week 48
measure: Percentage of Patients Improving ≥3 Steps on DRSS
timeFrame: Day 1 to Week 48
measure: Percentage of Patients Developing PDR
timeFrame: Day 1 to Week 48
measure: Percentage of Patients Developing PDR or ASNV
timeFrame: Day 1 to Week 48
measure: Percentage of Patients Developing Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR
timeFrame: Day 1 to Week 48
measure: Percentage of Patients Developing DME
timeFrame: Day 1 to Week 48
measure: Percentage of Patients With a ≥2-step or ≥3-step Worsening on DRSS
timeFrame: Day 1 to Week 48
measure: Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA
timeFrame: Day 1 to Week 48
measure: Time to First Development of PDR, ASNV, or DME
timeFrame: Day 1 to Week 48
measure: Time to First Development of PDR or ASNV
timeFrame: Day 1 to Week 48
measure: Time to First Development of Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR
timeFrame: Day 1 to Week 48
Other outcomes:
measure: Time to First Development of DME
timeFrame: Day 1 to Week 48
measure: Mean Change in OCT CST
timeFrame: Day 1 to Week 48
measure: Mean Change in BCVA
timeFrame: Day 1 to Week 48
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
state: Arizona
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
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 Maria
country: United States
facility: California Retina Consultants - Santa Maria
state: California
city: Danbury
country: United States
facility: Connecticut Eye Consultants
state: Connecticut
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
city: Clearwater
country: United States
facility: The Macula Center/ Blue Ocean Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Miami
country: United States
facility: Med Eye Associates
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina & Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Boise
country: United States
facility: Retina Specialists of Idaho
state: Idaho
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic LLP
state: Illinois
city: Lenexa
country: United States
facility: Retina Associates PA
state: Kansas
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants PC
state: Maryland
city: Grand Rapids
country: United States
facility: Foundation for Vision Research
state: Michigan
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular LLC
state: New Jersey
city: Hauppauge
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Hickory
country: United States
facility: Graystone Eye
state: North Carolina
city: Eugene
country: United States
facility: Cascade Medical Research Institute
state: Oregon
city: Bethlehem
country: United States
facility: MidAtlantic Retina
state: Pennsylvania
city: Beaufort
country: United States
facility: Charleston Neurosciences Institute
state: South Carolina
city: Charleston
country: United States
facility: Charleston Neuroscience Center
state: South Carolina
city: Knoxville
country: United States
facility: Southeastern Retina Associates PC
state: Tennessee
city: Memphis
country: United States
facility: Charles Retina Institute
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: Amarillo
country: United States
facility: Panhandle Eye Group, LLP
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas (Houston)
state: Texas
city: Burleson
country: United States
facility: Star Vision Consultants
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: San Antonio
country: United States
facility: Retina Consultants of San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas - (Woodlands)
state: Texas
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye
state: Washington
city: Pardubice
country: Czechia
facility: OFTEX s.r.o.
state: Pardubický Kraj
city: Praha 5
country: Czechia
facility: Axon Clinical, s.r.o.
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Rīga
country: Latvia
facility: Latvian American Eye Center
city: Warszawa
country: Poland
facility: Warszawski Szpital Okulistyczny
state: Mazowieckie
city: Gdansk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
state: Pomorskie
city: Bydgoszcz
country: Poland
facility: Oftalmika Sp. z o.o.
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center LLC
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta
city: Trencin
country: Slovakia
facility: Fakultna nemocnica Trencin
city: L'hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Hospital Universitari General de Catalunya - Grupo Quironsalud
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Majadanonda
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Kodiak Sciences Inc
name: Pablo Velazquez-Martin, MD
role: STUDY_DIRECTOR
affiliation: Kodiak Sciences Inc
name: Daniel Janer, MD
role: STUDY_DIRECTOR
References: