An Open-Label, Ascending-Exposure-Time, Single Center Trial to Evaluate the Pharmacokinetic Properties of Ocriplasmin (Generic Name of the Molecule Microplasmin) Intravitreal Injection in Subjects Scheduled for Primary Pars Plana Vitrectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.
研究概览
简要总结
To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)
详细描述
Open-label, ascending-exposure-time, single center trial in which a total of 36 subjects will be enrolled. The time to remove the vitreous will be recorded and a vitreous sample will be obtained at the beginning of vitrectomy for determination of ocriplasmin activity; 32 subjects will receive 125 μg ocriplasmin intravitreal injection prior to vitrectomy and 4 subjects will not receive ocriplasmin intravitreal injection prior to vitrectomy (control arm).
Study drug will be administered in the mid-vitreous by injection. The study eye will be examined after study drug injection to exclude retinal non-perfusion or other complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 18
- •Eye disease for which a primary vitrectomy is indicated
- •Best Corrected Visual Acuity (BCVA) of 20/800 or better in the non-study eye
- •Written informed consent obtained from the subject prior to inclusion in the trial
排除标准
- •Proliferative diabetic retinopathy.
- •Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either Optical Coherence Tomography (OCT) and/or fluorescein angiogram in the study eye
- •Aphakia in the study eye
- •High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).
- •Subjects with history of rhegmatogenous retinal detachment in the either eye
- •Subjects who have had ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior three months
- •Subjects who have had laser photocoagulation to the macula in the study eye at any time
- •Subjects with uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 26 mm Hg in spite of treatment with anti-glaucoma medication)
- •Subjects with a history of uveitis in either eye.
- •Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods of birth control include intrauterine device, oral, implanted, or injected contraceptives, and barrier methods with spermicide.
- •Subjects who, in the Investigators view, will not complete all visits and investigations
- •Subjects who have participated in an investigational drug trial within the past 30 days
- •Subjects who have previously participated in this trial
研究组 & 干预措施
PPV 5-30 minutes after injection
Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection
干预措施: ocriplasmin (Drug)
PPV 31-60 minutes after injection
Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection
干预措施: ocriplasmin (Drug)
PPV 2-4 hours after injection
Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection
干预措施: ocriplasmin (Drug)
PPV 24 hours (+2 hours) after injection
Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection
干预措施: ocriplasmin (Drug)
PPV 7 days (+1 day) after injection
Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection
干预措施: ocriplasmin (Drug)
结局指标
主要结局
Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.
时间窗: 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection
Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 \[5-30 minutes\]; Group 2 \[31-60 minutes\]; Group 3 \[2-4 hours\]; Group 4 \[24 hours ±2 hours\]; Group 5 \[7 days ±1 day\]. Subjects in Group 6 (control) did not receive the ocriplasmin injection.
次要结局
未报告次要终点