An extension study to protocol MD7108240; pazopanib eye drops in subjects with neovascolar age-related macular degeneration - ND
- Conditions
- eovascular age-related macular degenerationMedDRA version: 9.1Level: LLTClassification code 10025409Term: Macular degeneration
- Registration Number
- EUCTR2008-002101-39-IT
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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 < 450msec; or QTc < 480msec in subjects with Bundle Branch Block. 4 Subject is willing and able to return for all study visits, and is willing and able to comply with all protocol requirements and procedures. 5 Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is unable to read the consent form due to visual impairment then the consent must be read to the subject verbatim by person administering the consent, a family member or legally acceptable representative. If the subject is unable to provide written informed consent due to visual impairment, then written informed consent on behalf of the subject must be provided by a legally acceptable representative.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method