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

Part of paid clinical trials in Glendale, California.

Sponsor
Kodiak Sciences Inc
Study ID
NCT07734844
Phase
PHASE3
Status
Recruiting
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Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tabirafusp tedromer — DRUG
    Intravitreal injection
  • Aflibercept (2.0 mg) — DRUG
    Intravitreal injection

Study Details

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

Key Dates

First listed
Jul 29, 2026
Start date
Aug 3, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
910 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tabirafusp tedromer 5 mg Q8W
    Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by every-8-week dosing with additional individualized dosing (up to monthly dosing)
  • Experimental: Tabirafusp tedromer 5 mg Q4-24W
    Intravitreal injection of tabirafusp tedromer once every 4 weeks for 6 monthly doses followed by individualized dosing every 4 to 24 weeks.
  • Active Comparator: Aflibercept 2 mg
    Intravitreal injection of aflibercept once every 4 weeks for 5 monthly doses followed by every-8-week dosing

Primary Outcome Measure

Best corrected visual acuity (BCVA) [ Time Frame: Week 52 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Kodiak Research CenterGlendaleCalifornia91204-
Kodiak Research CenterPasadenaCalifornia91107-
Kodiak Research CenterSt. PetersburgFlorida33711-
Kodiak Research CenterHagerstownMaryland21740-
Kodiak Research CenterSaint Louis ParkMinnesota55416-
Kodiak Research CenterBeaufortSouth Carolina29902-
Kodiak Research CenterCharlestonSouth Carolina29414-
Kodiak Research CenterLadsonSouth Carolina29456-
Kodiak Research CenterWest ColumbiaSouth Carolina29169-

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