Recruiting
Phase 3

Tabirafusp Tedromer vs. Aflibercept

Sponsor:

Kodiak Sciences Inc

Code:

NCT07734844

Conditions

Diabetic Macular Edema (DME)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tabirafusp tedromer

Aflibercept (2.0 mg)

Study Details

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)

Study ID

NCT07734844

Start date

Aug 3, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

910 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tabirafusp tedromer 5 mg Q8W

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)

experimental: Tabirafusp tedromer 5 mg Q4-24W

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

active comparator: Aflibercept 2 mg

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

Interventions

Tabirafusp tedromer

Intravitreal injection

Aflibercept (2.0 mg)

Intravitreal injection

Primary outcome measure

  • Best corrected visual acuity (BCVA) [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Kodiak Sciences Inc

6502810850ClinicalTrials@kodiak.com

Locations

Kodiak Research Center

Recruiting

Glendale, California, United States, 91204

Kodiak Research Center

Recruiting

Pasadena, California, United States, 91107

Kodiak Research Center

Recruiting

St. Petersburg, Florida, United States, 33711

Kodiak Research Center

Recruiting

Hagerstown, Maryland, United States, 21740

Kodiak Research Center

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Kodiak Research Center

Recruiting

Beaufort, South Carolina, United States, 29902

Kodiak Research Center

Recruiting

Charleston, South Carolina, United States, 29414

Kodiak Research Center

Recruiting

Ladson, South Carolina, United States, 29456

Kodiak Research Center

Recruiting

West Columbia, South Carolina, United States, 29169

More Information

Sponsor

Kodiak Sciences Inc

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • DME
  • KSI-501
  • tabirafusp tedromer
  • aflibercept
  • antibody biopolymer conjugate
  • anti-VEGF
  • anti-IL-6
  • Kodiak Sciences

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kodiak Sciences Inc on 2026-08-21.