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
- Diseases
- Diabetic eye disease
- 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
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kodiak Research Center Coordinator of this site? Confirm its status | Caba | Argentina | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Comodoro Rivadavia | Argentina | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Mendoza | Argentina | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Amarillo | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Arlington | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Bakersfield | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Beaufort | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Cary | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Elmhurst | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Glendale | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Greensboro | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Hagerstown | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Hauppauge | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Hickory | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Katy | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Ladson | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Lynchburg | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Modesto | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Oxnard | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Pasadena | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Redlands | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Round Rock | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Saint Louis Park | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Schertz | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | St. Petersburg | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | The Woodlands | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Wake Forest | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Waterford | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | West Columbia | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
| Kodiak Research Center Coordinator of this site? Confirm its status | Winter Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.