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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06825702 | Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema | PHASE2 | RECRUITING | 28 | — | — | May 1, 2025 | Dec 1, 2026 | Apr 30, 2026 | 4 | Australia |
The primary objective is safety and tolerability. The incidence of AEs will be presented by System Organ Class (SOC) and Preferred Term (PT) by dose cohorts.
| Arm | Type | Description |
|---|---|---|
| Low Dose KIO-104: 2-weekly | EXPERIMENTAL | 2-weekly dosing |
| High Dose KIO-104: 2-weekly | EXPERIMENTAL | 2-weekly dosing |
| Low or High Dose KIO-104: 2-weekly | EXPERIMENTAL | 2-weekly dosing |
| Low or High Dose KIO-104: 4-weekly | EXPERIMENTAL | 4-weekly dosing |
| Name | Type | Description |
|---|---|---|
| KIO-104 | DRUG | KIO-104 is an ophthalmic formulation for IVT injection of the active pharmaceutical ingredient (API) KIO-100, a novel, non-steroidal, small molecule inhibitor of dihydroorotate dehydrogenase (DHODH). |
Inclusion Criteria: Participants must meet all the following criteria: 1. Be aged 18 to 85 years inclusive at the time of consent. 2. Provide informed consent prior to any study procedures, as stipulated by local laws, Ethics Committee (EC) and Regulatory Authority (RA) guidelines. 3. Be willing a...
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|---|---|---|---|---|
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