NCT07734844 A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
| NCT ID | NCT07734844 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kodiak Sciences Inc |
| Condition | Diabetic Macular Edema (DME) |
| Study Type | INTERVENTIONAL |
| Enrollment | 910 participants |
| Start Date | 2026-08-03 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 910 participants in total. It began in 2026-08-03 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
Eligibility Criteria
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
Contact & Investigator
J. Pablo Velazquez-Martin, MD
STUDY DIRECTOR
Kodiak Sciences Inc
Frequently Asked Questions
Who can join the NCT07734844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Macular Edema (DME). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07734844 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 910 participants.
Is NCT07734844 currently recruiting?
Yes, NCT07734844 is actively recruiting participants. Contact the research team at ClinicalTrials@kodiak.com for enrollment information.
Where is the NCT07734844 trial being conducted?
This trial is being conducted at Glendale, United States, Pasadena, United States, St. Petersburg, United States, Hagerstown, United States and 5 additional locations.
Who is sponsoring the NCT07734844 clinical trial?
NCT07734844 is sponsored by Kodiak Sciences Inc. The principal investigator is J. Pablo Velazquez-Martin, MD at Kodiak Sciences Inc. The trial plans to enroll 910 participants.