NCT07734844

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
910

participants targeted

Target at P75+ for phase_3

Timeline
37mo left

Started Aug 2026

Typical duration for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

May 30, 2026

Last Update Submit

July 24, 2026

Conditions

Diabetic Macular Edema (DME)

Keywords

DMEKSI-501tabirafusp tedromerafliberceptantibody biopolymer conjugateanti-VEGFanti-IL-6Kodiak Sciences

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity (BCVA)

    Mean change in BCVA from Day 1 to Year 1

    Week 52

Study Arms (3)

Tabirafusp tedromer 5 mg Q8W

EXPERIMENTAL

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 Q4-24W

EXPERIMENTAL

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 mg

ACTIVE COMPARATOR

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

Drug: Aflibercept (2.0 mg)

Interventions

Tabirafusp tedromerDRUG

Intravitreal injection

Also known as: KSI-501
Tabirafusp tedromer 5 mg Q4-24WTabirafusp tedromer 5 mg Q8W
Aflibercept (2.0 mg)DRUG

Intravitreal injection

Also known as: Eylea
Aflibercept 2 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

aflibercept

Study Officials

  • J. Pablo Velazquez-Martin, MD

    Kodiak Sciences Inc

    STUDY DIRECTOR

Central Study Contacts

Kodiak Sciences Inc

CONTACT

6502810850ClinicalTrials@kodiak.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized 5:3:5 into one of three treatment groups: tabirafusp-ted Q8W; tabirafusp-ted Q4-24W; or aflibercept.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2026

First Posted

July 29, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

July 29, 2026

Record last verified: 2026-07