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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06270836
Other study ID # KS301P108
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 1, 2024
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source Kodiak Sciences Inc
Contact Kodiak Sciences Inc.
Phone (650) 281-0850
Email ksi301clinical@kodiak.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 moderately severe to severe NPDR.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 30, 2025
Est. primary completion date December 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Signed informed consent prior to participation in the study. - Type 1 or 2 diabetes mellitus and HbA1c of =12%. - Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 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. - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tarcocimab
Intravitreal injection
Other:
Sham injection
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.

Locations

Country Name City State
Puerto Rico Emanuelli Research & Development Center, LLC Arecibo
United States Retina Research Institute of Texas Abilene Texas
United States Panhandle Eye Group, LLP. - Southwest Retina Specialists Amarillo Texas
United States Southeast Retina Center Augusta Georgia
United States Austin Retina Associates, PLLC (Austin) Austin Texas
United States Retina Consultants of Texas (Bellaire) Bellaire Texas
United States Mid Atlantic Retina Bethlehem Pennsylvania
United States Envision Ocular, LLC Bloomfield New Jersey
United States Star Vision Research Burleson Texas
United States Associated Vitreoretinal and Uveitis Consultants Carmel Indiana
United States Blue Ocean Clinical Research Clearwater Florida
United States Retina Group of Florida Fort Lauderdale Florida
United States Retina Consultants of Orange County Fullerton California
United States Global Research Management, Inc. - Lugene Eye Institute Glendale California
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Retina Consultants of Texas (Katy) Katy Texas
United States Southeastern Retina Associates PC Knoxville Tennessee
United States Piedmont Eye Center Lynchburg Virginia
United States Florida Eye Associates Melbourne Florida
United States Retinal Consultants Medical Group, Inc. Modesto California
United States Northern California Retina Vitreous Associates Mountain View California
United States Texas Retina Associates Plano Texas
United States Retina Consultants of Southern California Redlands California
United States Austin Retina Associates, PLLC (Round Rock) Round Rock Texas
United States Retinal Consultants Medical Group, Inc. Sacramento California
United States Retina Consultants of Texas (San Antonio) San Antonio Texas
United States Cascade Medical Research Institute Springfield Oregon
United States Springfield Clinic LLP Springfield Illinois
United States Retina Consultants of Texas (Woodlands) The Woodlands Texas
United States Retina Group of New England, PC Waterford Connecticut
United States Strategic Clinical Research Group, LLC Willow Park Texas
United States Center for Retina and Macular Disease Winter Haven Florida

Sponsors (1)

Lead Sponsor Collaborator
Kodiak Sciences Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy Sight-threatening complications include diabetic macular edema, proliferative diabetic retinopathy and anterior segment neovascularization Day 1 to Week 48
Secondary Proportion of eyes improving =3 steps on 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
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