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ranibizumab · 2 trials · 1 indication
Maintenance of vision was defined as a loss of \< 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.
Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Ranibizumab 0.5mg Q4 | ACTIVE_COMPARATOR | Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
| Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | EXPERIMENTAL | Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
| Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | EXPERIMENTAL | Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
| Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | EXPERIMENTAL | Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
| aflibercept injection 2.0mg Q4 | EXPERIMENTAL | - |
| aflibercept injection 0.5mg Q4 | EXPERIMENTAL | - |
| aflibercept injection 2.0mg Q8 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ranibizumab | DRUG | Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
| Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) | BIOLOGICAL | Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
| aflibercept injection (VEGF Trap-Eye, BAY86-5321) | BIOLOGICAL | Participants received a 2.0mg dose of aflibercept injection every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. |
Inclusion Criteria: * Signed informed consent. * Men and women \>/=50 years of age. * Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by Fluorescein angiography (FA) in the study eye. * ETDRS Best-Corrected Visual ...
Ranibizumab is a monoclonal antibody being developed for macular degeneration, specifically wet age-related macular degeneration (AMD). It is currently in Phase 3 clinical development and is considered investigational, meaning it has not yet been approved for use.
Ranibizumab is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in patients with macular degeneration.
Ranibizumab is in Phase 3 clinical development for the treatment of macular degeneration. It is an investigational drug, and its safety and efficacy have not yet been fully established. The Phase 3 trials have been completed, but the drug has not received regulatory approval.
Ranibizumab has been studied in two Phase 3 clinical trials: NCT00509795 and NCT00637377. Both trials were completed and evaluated the efficacy and safety of the drug in patients with wet age-related macular degeneration. The trials enrolled a total of 2,457 participants across multiple countries.
Ranibizumab targets vascular endothelial growth factor (VEGF), a protein that promotes the growth of abnormal blood vessels in the eye, which is a hallmark of wet age-related macular degeneration. By inhibiting VEGF, ranibizumab aims to reduce vascular leakage and prevent further vision loss.
Ranibizumab is a monoclonal antibody that targets VEGF, while aflibercept is a different drug that also inhibits VEGF but is a fusion protein. Both are used for macular degeneration, but they are distinct molecules with different structures and are developed by different companies.