A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)

NCT06270836 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: KS301P108
• Study Type: interventional
• Target: 255
• Locations: 2 countries
• Sites: 38

Brief Summary

This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with DR.

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

Outcome Measures

Primary Outcomes (1)

• Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)

  Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.

  Day 1 to Week 48

Secondary Outcomes (2)

• Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy

  Day 1 to Week 48

• Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)

  Day 1 to Week 48

Study Arms (2)

Tarcocimab 5 mg (Treatment Group A)

EXPERIMENTAL

Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44.

Drug: Tarcocimab

Treatment Group B

SHAM COMPARATOR

Sham injection on the same schedule as Treatment Group A

Other: Sham injection

Interventions

Tarcocimab DRUG

Intravitreal injection

Also known as: Tarcocimab tedromer, KSI-301

Tarcocimab 5 mg (Treatment Group A)

Sham injection OTHER

The sham injection 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 is performed to maintain masking of the study.

Treatment Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kodiak Sciences Inc: lead

Study Sites (38)

Retina Associates SW

Tucson, Arizona, 85704, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Global Research Management, Inc. - Lugene Eye Institute

Glendale, California, 91204, United States

Location

Retinal Consultants Medical Group, Inc.

Modesto, California, 95356, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95825, United States

Location

Retina Group of New England, PC

Waterford, Connecticut, 06385, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Springfield Clinic LLP

Springfield, Illinois, 62703, United States

Location

Associated Vitreoretinal and Uveitis Consultants

Carmel, Indiana, 46290, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Retina Consultants of Nevada

Henderson, Nevada, 89052, United States

Location

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

Location

Asheville Eye Associates

Asheville, North Carolina, 28803, United States

Location

North Carolina Retina Associates (Cary)

Cary, North Carolina, 27511, United States

Location

North Carolina Retina Associates (Wake Forest)

Wake Forest, North Carolina, 27587, United States

Location

Cascade Medical Research Institute

Springfield, Oregon, 97477, United States

Location

Erie Retina Research

Erie, Pennsylvania, 16507, United States

Location

Charleston Neuroscience Institute

Charleston, South Carolina, 29414, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Southeastern Retina Associates PC

Knoxville, Tennessee, 37922, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Panhandle Eye Group, LLP. - Southwest Retina Specialists

Amarillo, Texas, 79106, United States

Location

Austin Retina Associates, PLLC (Austin)

Austin, Texas, 78705-1169, United States

Location

Austin Research Center for Retina

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas (Bellaire)

Bellaire, Texas, 77401, United States

Location

Star Vision Research

Burleson, Texas, 76028, United States

Location

Retina Consultants of Texas (Katy)

Katy, Texas, 77494, United States

Location

Texas Retina Associates

Plano, Texas, 75075, United States

Location

Austin Retina Associates, PLLC (Round Rock)

Round Rock, Texas, 78681, United States

Location

Retina Consultants of Texas (San Antonio)

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas (Woodlands)

The Woodlands, Texas, 77384, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Pacific Northwest Retina (Bellevue)

Bellevue, Washington, 98004, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

Emanuelli Research & Development Center, LLC

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Retinal Degeneration; Retinal Diseases; Eye Diseases; Vision Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Eye Diseases, Hereditary; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pablo Velazquez-Martin, MD

  Kodiak Sciences Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 into one of two arms: KSI-301 or sham.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: May 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

US (37); PR (1)