NCT07734844 · Kodiak Sciences Inc
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
(ALTO)
What this study is about
A Study to Evaluate the effectiveness and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
View original scientific description
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
Interventions
DRUG
Tabirafusp tedromer
Intravitreal injection
DRUG
Aflibercept (2.0 mg)
Intravitreal injection
Primary outcome measures
Best corrected visual acuity (BCVA)
Time frame: Week 52
Mean change in BCVA from Day 1 to Year 1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Glendale, California
- Pasadena, California
- St. Petersburg, Florida
- Hagerstown, Maryland
- Saint Louis Park, Minnesota
- Beaufort, South Carolina
- Charleston, South Carolina
- Ladson, South Carolina
- West Columbia, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations