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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00637377 | Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) | PHASE3 | COMPLETED | 1,240 | — | — | Apr 1, 2008 | Aug 1, 2011 | Dec 12, 2014 | 189 | Argentina, Australia +24 |
| NCT00509795 | Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD) | PHASE3 | COMPLETED | 1,217 | — | — | Aug 1, 2007 | Jul 1, 2011 | Dec 28, 2012 | 188 | United States, Canada |
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 ...