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NCT07734844RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
910 (estimated)
First submitted
30 May 2026
Start date
3 Aug 2026
Primary completion date
31 Aug 2028
Lead sponsor
Kodiak Sciences Inc
NCT number
NCT07734844

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 910
  • From 3 Aug 2026 to the primary completion date, 31 Aug 2028
  • 46 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Current or history of retinal detachment (tractional or rhegmatogenous) in the Study Eye

Other

  • Active iris or angle neovascularization or neovascular glaucoma in the Study Eye.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kodiak Research Center
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CabaArgentinaRecruiting
Kodiak Research Center
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Comodoro RivadaviaArgentinaRecruiting
Kodiak Research Center
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MendozaArgentinaRecruiting
Kodiak Research Center
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RosarioArgentinaRecruiting
Kodiak Research Center
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AmarilloUnited StatesRecruiting
Kodiak Research Center
Coordinator of this site? Confirm its status
ArlingtonUnited StatesRecruiting
Kodiak Research Center
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
Kodiak Research Center
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BakersfieldUnited StatesRecruiting
Kodiak Research Center
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BeaufortUnited StatesRecruiting
Kodiak Research Center
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BellaireUnited StatesRecruiting
Kodiak Research Center
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BellevueUnited StatesRecruiting
Kodiak Research Center
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CaryUnited StatesRecruiting
Kodiak Research Center
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CharlestonUnited StatesRecruiting
Kodiak Research Center
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ElmhurstUnited StatesRecruiting
Kodiak Research Center
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Fort LauderdaleUnited StatesRecruiting
Kodiak Research Center
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Fort WorthUnited StatesRecruiting
Kodiak Research Center
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GlendaleUnited StatesRecruiting
Kodiak Research Center
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GreensboroUnited StatesRecruiting
Kodiak Research Center
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HagerstownUnited StatesRecruiting
Kodiak Research Center
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HauppaugeUnited StatesRecruiting
Kodiak Research Center
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HickoryUnited StatesRecruiting
Kodiak Research Center
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KatyUnited StatesRecruiting
Kodiak Research Center
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LadsonUnited StatesRecruiting
Kodiak Research Center
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LynchburgUnited StatesRecruiting
Kodiak Research Center
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MadisonUnited StatesRecruiting
Kodiak Research Center
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ModestoUnited StatesRecruiting
Kodiak Research Center
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Mt. PleasantUnited StatesRecruiting
Kodiak Research Center
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OxnardUnited StatesRecruiting
Kodiak Research Center
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PasadenaUnited StatesRecruiting
Kodiak Research Center
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PlanoUnited StatesRecruiting
Kodiak Research Center
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RedlandsUnited StatesRecruiting
Kodiak Research Center
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RochesterUnited StatesRecruiting
Kodiak Research Center
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Round RockUnited StatesRecruiting
Kodiak Research Center
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SacramentoUnited StatesRecruiting
Kodiak Research Center
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Saint Louis ParkUnited StatesRecruiting
Kodiak Research Center
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San AntonioUnited StatesRecruiting
Kodiak Research Center
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SchertzUnited StatesRecruiting
Kodiak Research Center
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ScottsdaleUnited StatesRecruiting
Kodiak Research Center
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Sioux FallsUnited StatesRecruiting
Kodiak Research Center
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St. PetersburgUnited StatesRecruiting
Kodiak Research Center
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The WoodlandsUnited StatesRecruiting
Kodiak Research Center
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Wake ForestUnited StatesRecruiting
Kodiak Research Center
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WaterfordUnited StatesRecruiting
Kodiak Research Center
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West ColumbiaUnited StatesRecruiting
Kodiak Research Center
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Winston-SalemUnited StatesRecruiting
Kodiak Research Center
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Winter HavenUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.