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A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants With DME - ALTO
RecruitingPhase 3
Sponsor: Kodiak Sciences Inc
Conditions: Diabetic Macular Edema (DME)
Interventions: Tabirafusp tedromer, Aflibercept (2.0 mg)
Countries: United States
A Study to Evaluate the Efficacy and Safety of Tabirafusp Tedromer Compared to Aflibercept in Participants with Diabetic Macular Edema - ALTO
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
Locations (9)
- Glendale, California, United States
- Pasadena, California, United States
- St. Petersburg, Florida, United States
- Hagerstown, Maryland, United States
- Saint Louis Park, Minnesota, United States
- Beaufort, South Carolina, United States
- Charleston, South Carolina, United States
- Ladson, South Carolina, United States
- West Columbia, South Carolina, United States