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Monoclonal Antibodies

Tarcocimab for Diabetic Retinopathy (GLOW2 Trial)

Phase 3
Recruiting
Research Sponsored by Kodiak Sciences Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 48
Awards & highlights

Summary

This trial will show that tarcocimab 5 mg is better than a fake treatment for people with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Who is the study for?
This trial is for people with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) who have type 1 or type 2 diabetes with an HbA1c of ≤12%. Participants should not have had previous intravitreal treatments for DR or DME, and must be able to delay certain retina treatments for at least 6 months. They also need good enough vision as defined by specific eye tests.
What is being tested?
The study is testing the effectiveness and safety of a drug called Tarcocimab Tedromer compared to a fake treatment (sham injection). The goal is to show that Tarcocimab can better treat NPDR in patients when given as an injection into the eye.
What are the potential side effects?
While the side effects of Tarcocimab are not detailed here, similar medications often cause eye-related issues like redness, discomfort, or increased pressure inside the eye. Systemic side effects may occur but would depend on individual patient reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
Secondary study objectives
Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy
Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tarcocimab 5 mg (Treatment Group A)Experimental Treatment1 Intervention
Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44.
Group II: Treatment Group BPlacebo Group1 Intervention
Sham injection on the same schedule as Treatment Group A

Find a Location

Who is running the clinical trial?

Kodiak Sciences IncLead Sponsor
8 Previous Clinical Trials
3,652 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
253 Patients Enrolled for Diabetic Retinopathy
Pablo Velazquez-Martin, MDStudy DirectorKodiak Sciences Inc
8 Previous Clinical Trials
3,652 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
253 Patients Enrolled for Diabetic Retinopathy
~167 spots leftby Dec 2025
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