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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03834753 | A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) | PHASE3 | COMPLETED | 228 | — | — | Jun 25, 2019 | Jul 8, 2021 | Mar 19, 2025 | 50 | United States |
| NCT03844074 | A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) | PHASE3 | COMPLETED | 61 | — | — | Oct 1, 2018 | Aug 13, 2020 | Mar 19, 2025 | 9 | Australia |
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.
| Arm | Type | Description |
|---|---|---|
| bevacizumab | EXPERIMENTAL | ONS-5010 |
| ranibizumab | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| bevacizumab | BIOLOGICAL | 1.25 mg, intravitreal injection |
| ranibizumab | BIOLOGICAL | 0.5mg, intravitreal injection |
Inclusion Criteria: * Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye * Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 Snellen equivalent) * Study eye must: * Have active leakage on Fluorescei...