Tarcocimab for Diabetic Retinopathy

(GLOW2 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tarcocimab to determine if it can more effectively treat diabetic retinopathy (an eye condition caused by diabetes that can lead to vision loss) compared to a sham (fake) treatment. Participants will receive an injection of either tarcocimab or a sham injection on a set schedule throughout the study. This trial may suit individuals with type 1 or type 2 diabetes who have diabetic retinopathy in one eye and have not received certain eye treatments in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that tarcocimab is likely to be safe for humans?

Research has shown that tarcocimab is generally safe and well-tolerated. One study found that serious eye-related side effects and inflammation inside the eye were similar between those who received tarcocimab and those who did not. However, caution is advised: the treatment's gel-like consistency might increase the risk of developing cataracts (clouding of the eye's lens) in people with diabetic retinopathy.

Overall, studies suggest tarcocimab is safe, but some risks, particularly related to cataracts, should be considered. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for diabetic retinopathy, which often include anti-VEGF injections like ranibizumab and aflibercept, Tarcocimab is unique because it targets a different pathway. This investigational drug is designed to inhibit a protein involved in the abnormal blood vessel growth and leakage that characterizes this condition. Researchers are excited about Tarcocimab because it offers a potential new mechanism of action that could provide benefits where other treatments may not fully succeed. Additionally, its dosing schedule—administered via intravitreal injection at key intervals—could improve convenience for patients by potentially reducing the frequency of treatments compared to current options.

What evidence suggests that tarcocimab might be an effective treatment for diabetic retinopathy?

Research has shown that tarcocimab effectively treats diabetic retinopathy (DR). Specifically, the GLOW study found that tarcocimab, administered less frequently, was more effective than a sham treatment for non-proliferative diabetic retinopathy, a type of DR. This means it improved the condition more than doing nothing. In this trial, participants in Treatment Group A will receive tarcocimab, while those in Treatment Group B will receive a sham injection. Tarcocimab blocks a protein that can cause harmful blood vessel growth in the eye, which can worsen DR. Previous successful results from three key studies support its potential to help people with DR. ^{1 2 3 4 6}

Who Is on the Research Team?

Pablo Velazquez-Martin, MD

Principal Investigator

Kodiak Sciences Inc

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2794551

Tarcocimab tedromer (KSI-301) 5mg: outcomes of the Phase 3 ... The results from the GLOW Study demonstrate that treatment with tarcocimab in a reduced dosing regimen is superior to sham for treatment of NPDR.

2. ir.kodiak.com ir.kodiak.com/news-releases/news-release-details/kodiak-sciences-completes-enrollment-second-registrational-trial

Kodiak Sciences Completes Enrollment in Second ... To date, tarcocimab has completed three successful Phase 3 pivotal clinical studies: the Phase 3 GLOW1 study in diabetic retinopathy ("DR"), the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05066230

NCT05066230 | A Study to Evaluate the Efficacy and ... This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy ( ...

4. ir.kodiak.com ir.kodiak.com/static-files/81652a63-b9bb-4b18-90ea-82963a805d4f

KSI-301 Anti-VEGF Antibody Biopolymer Conjugate for ... The gel-like consistency of tarcocimab results in a higher cataract incidence in diabetic patients with retinopathy. Can it be solved? An ...

5. prnewswire.com prnewswire.com/news-releases/kodiak-reboots-tarcocimab-tedromer-development-program-following-strong-positive-results-in-phase-3-diabetic-retinopathy-glow-study-and-following-dialogue-with-us-regulatory-authorities-on-a-regulatory-pathway-for-bla-submission-301978149.html

Kodiak reboots tarcocimab tedromer development program ... The primary endpoint is at one year. Outcomes include changes in diabetic retinopathy severity, measured on a standardized photographic grading ...

6. ir.kodiak.com ir.kodiak.com/news-releases/news-release-details/kodiak-sciences-announces-top-line-results-its-initial-phase-2b3

Kodiak Sciences Announces Top-Line Results from its initial ... Nearly 60% of KSI-301 patients achieved every 5-month dosing at year 1 with visual acuity gains and anatomic improvements comparable to the overall aflibercept ...