Neovascular age-related macular degeneration MedDRA version: 9.1 Level: LLT Classification code 10025409 Term: Macular degeneration
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Subjects who participated in Phase IIa study MD7108240 and who did not experience AMD disease progression requiring rescue therapy during pazopanib treatment or require discontinuation of pazopanib eye drops for safety reasons 2 Best-corrected ETDRS visual acuity in the study eye of 23 letters (20/320 or 4/63) or better at screening. 3 QTcB or QTcF =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and OCT. 2 Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD. 3 Intraocular surgery in the study eye within 3 months of dosing. 4 Use of topical ocular medications (other than pazopanib) in the study eye within 7 days of first dose of investigational product or expected use of topical ocular medications during the treatment period, with the exception of artificial tears. 5 Current use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol). 6 An unwillingness to refrain from wearing contact lenses starting from the screening visit, through the follow-up visit 7. ALT or AST above the upper limit of normal or total bilirubin ≥ 1.5 times the upper limit of normal at baseline. Note: Laboratory tests outside of the normal range may be repeated at the discretion of the Investigator. 8. Medical history or condition: Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%. Myocardial infarction or stroke within 6 months of screening. Active bleeding disorder. Major surgery within 1 month of screening. Hepatic impairment. 9. Uncontrolled hypertension, based on criteria provided in Section 7.2.2. Note: Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided the referenced criteria are met. 7 Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to the first dose of study medication. 8 A condition or situation which, in the opinion of the investigator, may result in significant risk to the subject, confound the study results or interfere significantly with participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the systemic and local safety and tolerability of repeat topical ocular doses of pazopanib when administered daily to adult subjects with CNV due to neovascular AMD;Secondary Objective: To determine the effect of repeat topical ocular doses of pazopanib on visual acuity when administered daily to adult subjects with CNV due to neovascular AMD. To determine the impact of repeat topical ocular doses of pazopanib on central retinal lesion thickness and retinal morphology To determine the impact of repeat topical ocular doses of pazopanib on CNV size and lesion size and characteristics;Primary end point(s): Safety and tolerability endpoints include ophthalmic examinations, vital signs (heart rate and blood pressure), clinical laboratory (including LFT monitoring), and adverse event reporting | — |
Countries
Belgium, Italy
Outcome results
None listed