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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01494805 | Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration | PHASE1 | COMPLETED | 40 | — | — | Dec 1, 2011 | Aug 1, 2017 | Sep 1, 2017 | 1 | Australia |
1. Ocular examination: * Ocular inflammation * Intraocular pressure * Visual acuity * Retinal bleeding 2. Abnormal laboratory data
| Arm | Type | Description |
|---|---|---|
| Low Dose rAAV.sFlt-1 | EXPERIMENTAL | - |
| High Dose rAAV.sFlt-1 | EXPERIMENTAL | - |
| Control - ranibizumab only | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| rAAV.sFlt-1 | BIOLOGICAL | 1 x 10\^10 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection |
| Control (ranibizumab alone) | OTHER | Patients will not receive rAAV.sFlt-1, but will be eligible for retreatment with ranibizumab (Lucentis). |
Inclusion Criteria: * Age greater than or equal to 55 years; * Subfoveal CNV secondary to AMD and with best corrected visual acuity of 3/60 - 6/9 with 6/60 or better in the other eye; * Fluorescein angiogram of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion, or...