A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)

Non-proliferative Diabetic Retinopathy Clinical Trial

— GLOW2  

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 Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) - GLOW2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270836
• Other study ID #: KS301P108
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Non-proliferative Diabetic Retinopathy
• Retinal Diseases

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