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

NCT07734844
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
910
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Lead sponsor
Kodiak Sciences Inc
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Start date
2026-08-03
clinicaltrials.gov
Number of sites
9
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Summary
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
clinicaltrials.gov
Acronym
ALTO
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Short title
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
clinicaltrials.gov
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-09-01
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First posted
2026-07-29
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Registry last updated
2026-08-21
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Primary completion date
2028-08-31
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Start date
2026-08-03
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Participants
910
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Participant count basis
Estimated
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Planned participants
910
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Protocol amendments
0
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Number of sites
9
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Kodiak Sciences Inc
clinicaltrials.gov
Source registry
ClinicalTrials.gov
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Registry ID
NCT07734844
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07734844
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Best corrected visual acuity (BCVA)

    Timeframe: Week 52

    Mean change in BCVA from Day 1 to Year 1

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Kodiak Research CenterGlendale, United StatesRecruiting
  • Kodiak Research CenterPasadena, United StatesRecruiting
  • Kodiak Research CenterSt. Petersburg, United StatesRecruiting
  • Kodiak Research CenterHagerstown, United StatesRecruiting
  • Kodiak Research CenterSaint Louis Park, United StatesRecruiting
  • Kodiak Research CenterBeaufort, United StatesRecruiting
  • Kodiak Research CenterCharleston, United StatesRecruiting
  • Kodiak Research CenterLadson, United StatesRecruiting
  • Kodiak Research CenterWest Columbia, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)