A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
255actual
Sites
39
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-05-01 | actual | When the study began enrolling |
| Primary completion | 2026-02-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-13 | actual | The whole study's end, after follow-up |
| First posted | 2024-02-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Diabetic Retinopathy
Interventions
- Drug: Tarcocimab — also filed as Tarcocimab tedromer, KSI-301
- Other: Sham injection
Primary outcome
what the primary-completion date above is the date OFProportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS)
measured Day 1 to Week 48
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