Safety, Tolerability and Efficacy of Intravitreal KIO-104 in Patients With Macular Edema
This is a multi-center, open label study to assess the safety, tolerability, and efficacy of KIO-104 administered by IVT injection to the study eye of eligible participants with macular edema.
| Condition(s) | Macular Edema |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a multi-center, open label study to assess the safety, tolerability, and efficacy of KIO-104 administered by IVT injection to the study eye of eligible participants with macular edema. |
| Who can participate | 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 and able to follow all study instructions, attend all study visits, and complete all study assessments. 4. Have a clinical diagnosis of ME in the study eye secondary to non-infectious uveitis, retinal vein occlusion, diabetic retinopathy or cataract surgery. 5. If currently receiving systemic corticosteroid therapy or immunosuppressive therapy (or any combination thereof), be on a stable dose of therapy for at least 3 months prior to Screening and during the study. 6. Have a Central Subfield Thickn |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Kiora Pharmaceuticals, Inc. |
| Locations | Sydney, New South Wales, Australia; Adelaide, South Australia, Australia; East Melbourne, Victoria, Australia; Nedlands, Western Australia, Australia |
| Start date | 2025-05-01 |
| NCT ID | NCT06825702 |
| Official listing | https://clinicaltrials.gov/study/NCT06825702 |