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pazopanib eye · 2 trials · 1 indication
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...
Pazopanib eye is an investigational small molecule being studied for the treatment of macular degeneration, specifically neovascular age-related macular degeneration. It is administered as eye drops and is currently in clinical development, with completed trials including a Phase 2 dose ranging study.
Pazopanib eye is a small molecule that targets vascular endothelial growth factor receptors, which play a role in abnormal blood vessel growth in the eye associated with macular degeneration. By inhibiting these receptors, it aims to reduce the progression of the disease.
Pazopanib eye is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company has conducted clinical trials to evaluate the safety and efficacy of this investigational treatment for macular degeneration.
Pazopanib eye has completed Phase 2 clinical trials for macular degeneration. It is an investigational drug and has not been approved by regulatory authorities. The development program includes two completed trials, with the most advanced being a Phase 2 dose ranging study.
Pazopanib eye has been evaluated in two completed clinical trials. NCT00659555 was a Phase 1 study assessing the effect of repeat dosing of ketoconazole on the pharmacokinetics of a single dose of pazopanib eye drops. NCT01134055 was a Phase 2 dose ranging study in patients with neovascular age-related macular degeneration.
Pazopanib eye is a topical formulation of pazopanib, the same active ingredient used in oral pazopanib tablets for cancer treatment. However, the eye drop formulation is being developed specifically for macular degeneration, with a different route of administration and dosing regimen.