Tabirafusp Tedromer for Diabetic Macular Edema
(ALTO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
Who Is on the Research Team?
J. Pablo Velazquez-Martin, MD
Principal Investigator
Kodiak Sciences Inc
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) with diabetic macular edema (DME), whether they've had treatment before or not. Participants must have type 1 or type 2 diabetes, an HbA1c of 12% or less, and be able to give informed consent.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Aflibercept
- Tabirafusp Tedromer
Trial Overview
The study compares two treatments for DME: a new drug called Tabirafusp tedromer versus the standard drug Aflibercept. Participants are randomly assigned to receive one of these medicines by injection into the eye.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing)
Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by individualized dosing every 4 to 24 weeks.
Intravitreal injection of aflibercept once every 4 weeks for 5 monthly doses followed by every-8-week dosing
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kodiak Sciences Inc
Lead Sponsor
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