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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02061865 | Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD | PHASE1 | COMPLETED | 12 | — | — | Feb 1, 2014 | Dec 1, 2014 | Feb 11, 2015 | 4 | United States |
The primary endpoint in the study is the incidence of treatment emergent adverse events (TEAEs) from day 1 through week 24 in patients treated with IVT REGN2176-3.
| Arm | Type | Description |
|---|---|---|
| Cohorts 1 - 4 | EXPERIMENTAL | Participants in cohort 1 will receive REGN2176-3 dosing regimen 1. Participants in cohort 2 will receive REGN2176-3 dosing regimen 2. Participants in cohort 3 will receive REGN2176-3 dosing regimen 3. Participants in cohort 4 will receive REGN2176-3 dosing regimen 4. |
| Name | Type | Description |
|---|---|---|
| REGN2176-3 | DRUG | - |
Inclusion Criteria: Key Criteria: Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD. Exclusion Criteria: 1. Any prior treatment with an inhibitor of PDGF (platelet-derived growth fa...