NCT06270836

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)

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 Diabetic Retinopathy (DR) - GLOW2

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Kodiak Sciences Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 DR.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2024-02-21
• Last updated: 2025-03-30

Locations

38 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study