Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as bevacizumab
ONS-5010 · 5 trials · 5 indications
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.
Number of participants with adverse events
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 |
|---|---|---|
| ONS-5010 bevacizumab | EXPERIMENTAL | - |
| ranibizumab | ACTIVE_COMPARATOR | - |
| Biological: bevacizumab | EXPERIMENTAL | - |
| bevacizumab | EXPERIMENTAL | ONS-5010 |
| 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 35-75 letters read (20/32 to 20/200 Snellen equivalent) * Study eye must: * Have active leakage on Fluorescein A...