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Monoclonal Antibodies

Tarcocimab 5 mg (Treatment Group A) 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

GLOW2 Trial 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.Check my eligibility

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.See study design

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.

GLOW2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to week 48

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)

Secondary outcome measures

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)

GLOW2 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kodiak Sciences IncLead Sponsor

7 Previous Clinical Trials

2,976 Total Patients Enrolled

1 Trials studying Diabetic Retinopathy

253 Patients Enrolled for Diabetic Retinopathy

Pablo Velazquez-Martin, MDStudy DirectorKodiak Sciences Inc

5 Previous Clinical Trials

1,850 Total Patients Enrolled

1 Trials studying Diabetic Retinopathy

253 Patients Enrolled for Diabetic Retinopathy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on the count of participants involved in this study?

"Indeed, the details on clinicaltrials.gov specify that this investigation is actively enrolling subjects. The trial was first listed on March 27th, 2024 and had its latest update on April 4th, 2024. To fill the study quota, they are seeking to enroll a total of 250 participants at various locations across 21 sites."

Answered by AI

Are numerous medical facilities conducting this study in Canada?

"A total of 21 participants are currently being enrolled in this clinical trial, with recruitment taking place at various esteemed institutions including Star Vision Research in Burleson, Cascade Medical Research Institute in Springfield, and Retina Consultants of Orange County in Fullerton. Additionally, there are 18 more sites involved in participant enrollment."

Answered by AI

What are the potential risks of administering Tarcocimab 5 mg to individuals in Treatment Group A?

"Our team at Power has rated the safety of Tarcocimab 5 mg (Treatment Group A) as a level 3 on our scale. This assessment is based on the trial being in Phase 3, indicating both existing efficacy data and robust safety data from multiple evaluations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2024. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06270836.

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