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

Purpose

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

Condition

  • Diabetic Macular Edema (DME)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized 5:3:5 into one of three treatment groups: tabirafusp-ted Q8W; tabirafusp-ted Q4-24W; or aflibercept.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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)
  • Drug: Tabirafusp tedromer
    Intravitreal injection
    Other names:
    • KSI-501
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.
  • Drug: Tabirafusp tedromer
    Intravitreal injection
    Other names:
    • KSI-501
Active Comparator
Aflibercept 2 mg 		Intravitreal injection of aflibercept once every 4 weeks for 5 monthly doses followed by every-8-week dosing
  • Drug: Aflibercept (2.0 mg)
    Intravitreal injection
    Other names:
    • Eylea

Recruiting Locations

Kodiak Research Center
Glendale, California 91204

Kodiak Research Center
Pasadena, California 91107

Kodiak Research Center
St. Petersburg, Florida 33711

Kodiak Research Center
Hagerstown, Maryland 21740

Kodiak Research Center
Saint Louis Park, Minnesota 55416

Kodiak Research Center
Beaufort, South Carolina 29902

Kodiak Research Center
Charleston, South Carolina 29414

Kodiak Research Center
Ladson, South Carolina 29456

Kodiak Research Center
West Columbia, South Carolina 29169

More Details

Status
Recruiting
Sponsor
Kodiak Sciences Inc

Study Contact

Kodiak Sciences Inc
6502810850
ClinicalTrials@kodiak.com