EUCTR2008-002101-39-BE进行中（未招募）不适用
An extension study to protocol MD7108240; pazopanib eye drops in subjects with neovascular age-related macular degeneration
GlaxoSmithKiline Research and Development0 个研究点目标入组 75 人开始时间: 2008年10月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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.
- •(Note: Consent by legally acceptable representative is allowed where this is in
- •accordance with local laws, regulations and ethics committee policy.)
- •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
排除标准
- •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.
- •10. Use of prohibited medications listed in Section 9.2 within the restricted timeframe relative to the first dose of study medication.
- •11. 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.
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