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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01134055 | Dose Ranging Study of Pazopanib to Treat Neovascular Age-Related Macular Degeneration | PHASE2 | COMPLETED | 510 | — | — | Jun 1, 2010 | Oct 1, 2012 | Jan 8, 2018 | 77 | United States, Australia +7 |
| NCT00659555 | Study Of The Repeat Dosing Of Ketoconazole On The Pharmacokinetics Of A Single Dose Of Pazopanib (GW786034) Eye Drops | PHASE1 | COMPLETED | 24 | — | — | Apr 4, 2008 | May 10, 2008 | Nov 13, 2017 | 1 | United States |
BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
| Arm | Type | Description |
|---|---|---|
| investigational arm 1 | EXPERIMENTAL | 5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection |
| investigational arm 2 | EXPERIMENTAL | 5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection |
| investigational arm 3 | EXPERIMENTAL | 10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection |
| investigational arm 4 | EXPERIMENTAL | 10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection |
| investigational arm 5 | EXPERIMENTAL | 10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection |
| placebo control arm | PLACEBO_COMPARATOR | Placebo eye drops QID with allowance for as-needed ranibizumab injection |
| active open-label control arm | ACTIVE_COMPARATOR | Ranibizumab intravitreal injection every 4 weeks |
| Treatment A receivers | EXPERIMENTAL | Subjects received pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution in Period 1 |
| Treatment B receivers | EXPERIMENTAL | Subjects received ketoconazole, daily 400 mg oral dose on Days 1 to 8; pazopanib, single dose as 2 x 40 microliter drops of 5 mg/mL solution on Day 5 in Period 2 |
| Name | Type | Description |
|---|---|---|
| pazopanib eye drops | DRUG | A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors. |
| placebo | DRUG | placebo eye drops |
| ranibizumab intravitreal injection | BIOLOGICAL | Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A |
| Ketoconozole tablets | DRUG | Ketoconozole will be administered as tablets via oral route. Ketoconozole tablets will be present as white, rounded, scored tablets |
Inclusion Criteria: * Men and women aged ≥50 years. * Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area. * Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and i...