Tabirafusp Tedromer vs Aflibercept for Diabetic Macular Edema (DME)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares Tabirafusp Tedromer to Aflibercept 2.0 mg in adults with DME. Participants are randomized to receive either the experimental antibody biopolymer conjugate or the standard anti-VEGF therapy, with safety and efficacy monitored over time. Eligible participants include adults with diabetes and DME, regardless of prior treatment status, who meet specific health criteria. Primary outcomes typically include changes in vision and retinal thickness, along with safety assessments. The study is conducted at Kodiak Research Centers in Scottsdale, Bakersfield, and Glendale, California.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* DME, treatment-naïve or previously-treated
* Male or female ≥18 years of age with Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%
* Capable of giving informed signed consent

Exclusion Criteria:

* Active iris or angle neovascularization or neovascular glaucoma in the Study Eye.
* Current or history of retinal detachment (tractional or rhegmatogenous) in the Study Eye

Where it's running

• Kodiak Research Center
  Scottsdale, Arizona, United States Recruiting
• Kodiak Research Center
  Bakersfield, California, United States Recruiting
• Kodiak Research Center
  Glendale, California, United States Recruiting
• Kodiak Research Center
  Modesto, California, United States Recruiting
• Kodiak Research Center
  Oxnard, California, United States Recruiting
• Kodiak Research Center
  Pasadena, California, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Kodiak Sciences Inc
• Email: ClinicalTrials@kodiak.com
• Phone: 6502810850

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.