A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO | NCT07734844

NCT07734844

Overview

NCT ID: NCT07734844
Lead Sponsor: Kodiak Sciences IncINDUSTRY
Official Title: A Randomized, Double-masked, Active-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Tedromer 5 mg Compared With Intravitreal Aflibercept 2 mg in Participants With Visual Impairment Secondary to Diabetic Macular Edema (DME) - ALTO
Brief Summary: A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
Conditions: Diabetic Macular Edema (DME)
Interventions: Tabirafusp tedromer
Aflibercept (2.0 mg)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Aug 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Phase 3
Enrollment: 910Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Kodiak Sciences IncContact
ClinicalTrials@kodiak.com6502810850

Similar Studies

Participant Group/Arms

Tabirafusp tedromer 5 mg Q8WExperimental

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)

Drug: Tabirafusp tedromer

Tabirafusp tedromer 5 mg Q4-24WExperimental

Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by individualized dosing every 4 to 24 weeks.

Drug: Tabirafusp tedromer

Aflibercept 2 mgActive Comparator

Intravitreal injection of aflibercept once every 4 weeks for 5 monthly doses followed by every-8-week dosing

Drug: Aflibercept (2.0 mg)