910 Participants NeededMy employer runs this trial

Tabirafusp Tedromer for Diabetic Macular Edema

(ALTO Trial)

Recruiting at 8 trial locations
KS
Overseen ByKodiak Sciences Inc
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Kodiak Sciences Inc
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

JP

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

I have diabetic macular edema, whether or not I have had treatment before.
I am 18 or older with Type 1 or Type 2 diabetes and my HbA1c is 12% or less.
I am able to understand and sign a consent form.

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

Group I: Tabirafusp tedromer 5 mg Q8WExperimental Treatment1 Intervention
Group II: Tabirafusp tedromer 5 mg Q4-24WExperimental Treatment1 Intervention
Group III: Aflibercept 2 mgActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kodiak Sciences Inc

Lead Sponsor

Trials
9
Recruited
3,900+