NCT01086761终止1 期
A Phase I/II, Open-label, Non-controlled, Escalating Dose, Multicentre Clinical Trial Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetics of MP0112 Injected Intravitreally in Patients With Wet Age Related Macular Degeneration (AMD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 32
- 试验地点
- 16
- 主要终点
- Maximal Tolerated Dose (MTD) Following a Single Injection
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of MP0112 (a novel, potentially long acting VEGF inhibitor) in patients with wet Age Related Macular Degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and angiographic evidence of active primary progressive subfoveal choroidal neovascularisation (CNV), including juxtafoveal lesions that affect the fovea on FA in the study eye that is at least 50% of the total lesion area
- •ETDRS best-corrected visual acuity of: 20/40 to 20/320 in the study eye at 4 meters
- •Male or female age > 50 years
- •Written informed consent prior to any study procedures
- •Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
排除标准
- •Prior treatment with anti-VEGF therapy in the study eye, including bevacizumab, ranibizumab, or pegaptanib, as well as photodynamic therapy with verteporfin
- •Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins
- •Subfoveal thermal laser therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- •Extrafoveal laser coagulation treatment within 12 weeks prior to Baseline in the study eye
- •Total lesion size > 20mm2 (including blood, scars and neovascularization) as assessed by FA in the study eye
- •Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 2.54mm2 or more in size in the study eye
- •Scar or fibrosis, making up > 50% of total lesion in the study eye
- •Scar, fibrosis, or atrophy involving the center of the fovea
- •Presence of retinal pigment epithelial tears or rips
- •History of any vitreous hemorrhage within 4 weeks prior to Visit 1 or current hemorrhage in the study eye
- •Presence of other causes of CNV, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye
- •History or clinical evidence of diabetic retinopathy, diabetic macular oedema or any other vascular disease affecting the retina, other than AMD, in either eye
- •Prior vitrectomy in the study eye
- •History of retinal detachment or treatment or surgery for retinal detachment in the study eye
- •Ocular surgery (including cataract removal) in the study eye within 3 months of enrolment
- •Active intraocular inflammation (grade trace or above) in the study eye
- •History of allergy to any components of the study drug or diagnostic devices, such as fluorescein
- •Advanced glaucoma or intraocular pressure above 22 mmHg in the study eye despite treatment
- •Inability to obtain fundus photographs or fluorescein angiogram of sufficient quality to be analyzed and graded by the central reading center
- •History of idiopathic or autoimmune-associated uveitis in either eye
- •Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Aphakia or absence of the posterior capsule in the study eye
- •Presence of a non-healing wound, ulcer, fracture or any other medical condition associated with bleeding
- •Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of enrolment
- •Premenopausal women
- •Any disorder or condition that contraindicates the use of an investigational drug
- •Participation in another investigational drug study within 3 months of enrolment
- •Uncontrolled hypertension
- •Previous stroke within 12 months of study entry
- •Systemic treatment with any anti-VEGF drug
- •Current treatment for active systemic infection
结局指标
主要结局
Maximal Tolerated Dose (MTD) Following a Single Injection
时间窗: 16 weeks
MTD was defined as one dose level below the lower of the dose level in which a severe (sight-threatening) drug-related Adverse Event occurred or the dose level at which more than 2 patients experienced a moderate ocular (eye) drug-related toxicity.
次要结局
- Percentage of Participants With Stable or Improved Best Corrected Visual Acuity (BCVA)(Baseline, Week 4)
- Change From Baseline in Central Area Retinal Thickness(Baseline, Week 4)
- Area of Leakage as Measured by Fluorescein Angiography(Baseline, Week 4)
- Area of Lesion as Measured by Fluorescein Angiography(Baseline, Week 4)
- Maximum Serum Concentration (Cmax) of MP0112 at Day 3(Day 3)
- Number of Participants With Positive Binding Anti-MP0112 Antibodies(12 weeks)
研究者
研究点 (16)
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