Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06270836 | A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Diabetic Retinopathy (DR) | PHASE3 | COMPLETED | 255 | — | — | May 1, 2024 | Feb 13, 2026 | May 13, 2026 | 39 | United States, Puerto Rico |
Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), on a scale from 10 to 90, where lower scores represent better outcomes.
| Arm | Type | Description |
|---|---|---|
| Tarcocimab 5 mg (Treatment Group A) | EXPERIMENTAL | Tarcocimab 5 mg via intravitreal injection at Day 1, Week 4, Week 8, Week 20, and Week 44. |
| Treatment Group B | SHAM_COMPARATOR | Sham injection on the same schedule as Treatment Group A |
| Name | Type | Description |
|---|---|---|
| Tarcocimab | DRUG | Intravitreal injection |
| Sham injection | OTHER | The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study. |
Inclusion Criteria: * Signed informed consent prior to participation in the study. * Type 1 or 2 diabetes mellitus and HbA1c of ≤12%. * DR in the Study Eye (DRSS as determined by the reading center based on color fundus photographs), who have not previously received intravitreal medications for DR ...