Clinical trial NCT06270836: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)
Official title: A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants With Diabetic Retinopathy (DR) - GLOW2
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: 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
Tarcocimab Tedromer
Tarcocimab
Diabetic Eye Disease
Lead sponsor: Kodiak Sciences Inc
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 255
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 study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.

Detailed description: This is a prospective, randomized, double-masked, two-arm, multi-center Phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment, with respect to the proportion of eyes improving from baseline at Week 48 in participants with DR.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to participation in the study.
* Type 1 or 2 diabetes mellitus and HbA1c of ≤12%.
* DR in the Study Eye (DRSS as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR or DME, and in whom pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
* CST ≤320 microns and a BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) in the Study Eye at screening and confirmed at Day 1; OR
* CST \>320 and ≤350 microns and a BCVA ETDRS letter score in the Study Eye of ≥79 letters (approximate Snellen equivalent of 20/25 or better) in the Study Eye at screening and confirmed at Day 1.

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 within the last twelve (12) months prior to Day 1.
* Prior intravitreal or periocular steroid in the Study Eye for DR or DME within the last twelve (12) months prior to Day 1.
* Prior use of an investigational intravitreal treatment for DR or DME in the Study Eye.
* History of vitreoretinal surgery in the Study Eye.
* History of uveitis in either eye.
* Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
* Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT, or FP.
* 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: Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
timeFrame: Day 1 to Week 48
Secondary outcomes:
measure: Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy
timeFrame: Day 1 to Week 48
measure: Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
timeFrame: Day 1 to Week 48
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Associates SW
state: Arizona
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Glendale
country: United States
facility: Global Research Management, Inc. - Lugene Eye Institute
state: California
city: Modesto
country: United States
facility: Retinal Consultants Medical Group, Inc.
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: Waterford
country: United States
facility: Retina Group of New England, PC
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Springfield
country: United States
facility: Springfield Clinic LLP
state: Illinois
city: Carmel
country: United States
facility: Associated Vitreoretinal and Uveitis Consultants
state: Indiana
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Henderson
country: United States
facility: Retina Consultants of Nevada
state: Nevada
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Asheville
country: United States
facility: Asheville Eye Associates
state: North Carolina
city: Cary
country: United States
facility: North Carolina Retina Associates (Cary)
state: North Carolina
city: Wake Forest
country: United States
facility: North Carolina Retina Associates (Wake Forest)
state: North Carolina
city: Springfield
country: United States
facility: Cascade Medical Research Institute
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Knoxville
country: United States
facility: Southeastern Retina Associates 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. - Southwest Retina Specialists
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates, PLLC (Austin)
state: Texas
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas (Bellaire)
state: Texas
city: Burleson
country: United States
facility: Star Vision Research
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, PLLC (Round Rock)
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas (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: Bellevue
country: United States
facility: Pacific Northwest Retina (Bellevue)
state: Washington
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
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: