Conditions: Macular Degeneration
Keywords: angiogenesis pazopanib, age-related macular degeneration (AMD), vascular endothelial growth factor (VEGF), choroidal neovascularization (CNV),
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
This is a 28 day study to evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients

Detailed description:
Pazopanib has been formulated as an eye drop for the topical treatment of age-related macular degeneration (AMD). Safety, tolerability and pharmacokinetics have been evaluated in a first study conducted in healthy volunteers (MD7108238). In the present study, three dosing regimens of pazopanib eye drops, administered for 28 days, will be evaluated in subjects with occult or minimally classic subtypes of choroidal neovascularization due to AMD. This study is designed to measure pharmacological activity of topically administered pazopanib in target tissues (choroid and retina) of patients with AMD by weekly evaluation of central retinal thickness as measured by optical coherence tomography (OCT). Evaluation of efficacy will be performed on an exploratory basis by weekly measurement of visual acuity. The ocular and systemic safety and systemic pharmacokinetics of pazopanib treatment for 28 days will also be evaluated.

Arms:
arm 1: Pazopanib eye drops formulation 5 mg/mL daily for 28 days arm 2: Pazopanib eye drop formulation 5mg/mL TID for 28 days arm 3: Pazopanib eye drop formulation 2mg/mL TID for 28 days

Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: Pazopanib eye drops formulation

Protocol document: