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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00051129 | Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD) | PHASE3 | COMPLETED | 291 | — | — | Jan 1, 2007 | May 1, 2008 | Nov 28, 2012 | - | — |
| NCT00299507 | Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD) | PHASE3 | COMPLETED | 240 | — | — | Mar 1, 2005 | Apr 1, 2008 | Nov 28, 2012 | 1 | United States |
| NCT00041483 | Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD | PHASE3 | COMPLETED | 530 | — | — | Jun 1, 2002 | Aug 1, 2005 | Jul 1, 2014 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Anecortave Acetate | EXPERIMENTAL | Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18) |
| Anecortave Acetate Vehicle | PLACEBO_COMPARATOR | Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18) |
| 15 mg Anecortave Acetate, 3 month intervals | EXPERIMENTAL | Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months). |
| 15 mg Anecortave Acetate, 6 month intervals | EXPERIMENTAL | Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). |
| 30 mg Anecortave Acetate, 6 month intervals | EXPERIMENTAL | Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months). |
| Anecortave and Sham PDT | ACTIVE_COMPARATOR | - |
| PDT and Sham Anecortave Acetate | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Anecortave Acetate 15 mg sterile suspension | DRUG | 0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection |
| Anecortave Acetate Vehicle | OTHER | Administered as a posterior juxtascleral injection |
| Anecortave Acetate Sterile Suspension, 30 mg/mL | DRUG | One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals |
| Anecortave Acetate Sterile Suspension, 60 mg/mL | DRUG | One 0.5 mL posterior juxtascleral depot injection at 6 month intervals |
| Photodynamic Therapy (PDT) | OTHER | - |
Inclusion Criteria: * Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Under 50 years. * Other protocol-defined exclusion criteria may apply.