A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO

ConditionDiabetic Macular Edema (DME)

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorKodiak Sciences Inc

About this trial

A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Tabirafusp tedromer
Drug
Intravitreal injection
Aflibercept (2.0 mg)
Drug
Intravitreal injection

Treatment groups

910 Participants

are divided into 3 treatment groups

Group A: Tabirafusp tedromer 5 mg Q8WExperimental treatment 1 intervention

Group B: Tabirafusp tedromer 5 mg Q4-24WExperimental treatment 1 intervention

Group C: Aflibercept 2 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

Best corrected visual acuity (BCVA)

Mean change in BCVA from Day 1 to Year 1

Time frame

Week 52

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kodiak Sciences Inc

Lead sponsor

Source ClinicalTrials.gov

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