Neovascular age-related macular degeneration MedDRA version: 9.1 Level: LLT Classification code 10025409 Term: Macular degeneration
Conditions
Interventions
Product Name: pazopanib
Product Code: GW786034
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: pazopanib
CAS Number: 635702-64-6
Current Sponsor code: GW786034B
Concentration unit: mg/m
Sponsors
GlaxoSmithKline Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye, with all of the following characteristics required: central subfield thickness > 300 microns on investigator-determined OCT (inclusive of subretinal fluid); active subfoveal leakage as determined by investigator-determined fluorescein angiography; minimally classic or occult with no classic CNV lesion; lesion size no greater than 12 disc areas; CNV > 50% of lesion area; = 50 years of age. 3.Best-corrected ETDRS visual acuity in the study eye between 80 to 24 letters inclusive (approximately 20/25 to 20/320 or 4/5 to 4/63) at screening. 4.A female subject is eligible to participate if she is of non-childbearing potential defined as either pre-menopausal with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases of postmenopausal status a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Additional eye disease in the study eye that could compromise best corrected visual acuity (i.e. glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, or retinitis pigmentosa). 2.CNV in the study eye due to other causes unrelated to age-related macular degeneration.3.The presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required).4.Geographic atrophy involving the center of the fovea in the study eye. 5.Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and OCT.6.Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD.7.More than one prior photodynamic therapy (PDT) treatment in the study eye. 8.PDT treatment in the study eye 10 mg prednisone or equivalent/day) within 14 days of first dose.18.An unwillingness to refrain from wearing contact lenses starting from the screening visit, through the follow-up visit. 19.Medical history or condition:Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%; Myocardial infarction or stroke within 12 months of screening; Active bleeding disorder; Major surgery within 1 month of screening.; Hepatic impairment.20.Uncontrolled hypertension, based on criteria provided in Section 7.2.2.21.ALT or AST above the upper limit of normal or total bilirubin values at or above 1.5 times the upper limit of normal at screening. Note: Laboratory tests outside of the normal range may be repeated at the discretion of the Investigator.22.A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.23.A history of known HIV infection.24.Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to the first dose of study medication.25.History of drug or alcohol abuse within 6 months of the study.26.History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.27.A condition or situation which, in the opinion of the investigator, may result in significant risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of repeat topical ocular doses of pazopanib on central retinal/lesion thickness, when administered daily for 28 days to adult patients with subfoveal CNV due to neovascular (wet) AMD.;Secondary Objective: 1. To determine the systemic and local safety of repeat topical ocular doses of pazopanib when administered daily for 28 days to adult patients with subfoveal CNV due to neovascular AMD 2. To determine the effect of repeat topical ocular doses of pazopanib on best corrected protocol visual acuity when administered daily for 28 days to adult patients with subfoveal CNV due to neovascular AMD 3. To determine the impact of repeat topical ocular doses of pazopanib on retinal morphology and choroidal neovascular size and lesion size (area) 4. To assess the systemic pharmacokinetics of repeat topical ocular doses of pazopanib;Primary end point(s): Mean change from baseline in central retinal/lesion thickness as measured by the Carl Zeiss Meditec Stratus OCT scanner. | — |
Countries
Belgium, Italy
Outcome results
None listed