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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01024998 | Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD) | PHASE1 | COMPLETED | 19 | — | — | Jan 11, 2010 | Jul 1, 2018 | Aug 22, 2018 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| 2 x 10^8 vector genomes (vg) AAV2-sFLT01 | EXPERIMENTAL | - |
| 2 x 10^9 vector genomes (vg) AAV2-sFLT01 | EXPERIMENTAL | - |
| 6 x 10^9 vector genomes (vg) AAV2-sFLT01 | EXPERIMENTAL | - |
| 2 x 10^10 vector genomes (vg) AAV2-sFLT01 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AAV2-sFLT01 | BIOLOGICAL | 2 x 10\^8 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL. |
Inclusion Criteria: * Choroidal neovascular membrane (CNV) secondary to AMD, as confirmed by the patient's medical history and a documented diagnosis of CNV. * Distance BCVA of 20/100 or worse in the study eye. * The fellow eye must have distance BCVA of 20/400 or better. * The study eye, i.e., the...