Approval Probability
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Adjusted LOA
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ranibizumab · 3 trials · 3 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.
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 | - |
| 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...
Ranibizumab is a monoclonal antibody being developed for neovascular age-related macular degeneration (AMD), also known as wet AMD. It is intended to treat this condition, which affects the retina and can lead to vision loss. The drug is currently in clinical development for this indication.
Ranibizumab targets vascular endothelial growth factor (VEGF), a protein that promotes abnormal blood vessel growth in the eye. By binding to VEGF, ranibizumab aims to reduce this growth and leakage, which are hallmarks of neovascular age-related macular degeneration. This mechanism is central to its intended therapeutic effect.
Ranibizumab is being developed by Outlook Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol OTLK. Outlook Therapeutics is conducting clinical trials to evaluate the drug's safety and efficacy for treating neovascular age-related macular degeneration.
Ranibizumab is in Phase 3 clinical development. It has completed multiple Phase 3 trials, including studies with enrollment of 228, 61, and 400 participants. These trials were conducted in the United States and Australia, and all have been completed. The drug is investigational and not yet approved.
Ranibizumab has been studied in three completed Phase 3 trials: NCT03834753 (228 participants in the US), NCT03844074 (61 participants in Australia), and NCT06190093 (400 participants in the US). All trials evaluated the drug for neovascular age-related macular degeneration and were randomized, double-blind, and active-controlled.
Yes, ranibizumab is also known as ONS-5010. The clinical trials for ranibizumab, such as NCT03834753 and NCT06190093, are titled as studies of ONS-5010 in subjects with neovascular age-related macular degeneration. This alternative name is used in the context of Outlook Therapeutics' development program.