Tarcocimab for Diabetic Retinopathy

(GLOW2 Trial)

Recruiting at 41 trial locations

Overseen By Kodiak Sciences Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kodiak Sciences Inc

Must not be taking: Anti-VEGF, Steroids

Disqualifiers: Prior PRP, Neovascularization, Vitreous hemorrhage, Retinal detachment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 48 weeks

255 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have received certain eye treatments in the past year.

What is the purpose of this trial?

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

Research Team

Pablo Velazquez-Martin, MD

Principal Investigator

Kodiak Sciences Inc

Eligibility Criteria

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.

Inclusion Criteria

My eye condition is severe but hasn't been treated with injections or laser yet.

My vision in the study eye is 20/40 or better, OR my vision is 20/25 or better if my eye thickness is slightly increased.

I have diabetes and my HbA1c level is 12% or lower.

Exclusion Criteria

Prior PRP in the Study Eye

I have had steroid treatment in my eye for diabetic retinopathy or macular edema.

My eye has blood vessel growth, bleeding, or detachment issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tarcocimab 5 mg or sham treatment via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44

48 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tarcocimab

Trial Overview 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.

Participant Groups

Group I: Tarcocimab 5 mg (Treatment Group A) Experimental Treatment 1 Intervention

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

Group II: Treatment Group B Placebo Group 1 Intervention

Sham injection on the same schedule as Treatment Group A

Who Is Running the Clinical Trial?

Kodiak Sciences Inc

Lead Sponsor

Trials

9

Recruited

3,900+