Prospective, Non-Randomized, Open-Label, Multi-Center, Single Arm Study of Exchange of Travoprost Intraocular Implant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 14
- 主要终点
- Ocular Safety
研究概览
简要总结
The study objective is to evaluate the safety of the operative and surgical exchange procedure of Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension.
详细描述
This prospective, non-randomized, open-label, multi-center, single arm, clinical trial intends to implant approximately 45 male and female subjects over 18 years old who have been diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). All subjects are required to meet eligibility criteria at Visit 1 (Screening). The purpose of this study is to evaluate the safety of the implantation and exchange of a Travoprost Intraocular Implant in subjects with open-angle glaucoma or ocular hypertension. Postoperatively, there are 6 follow-up visits over a 12 month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Able and willing to attend scheduled follow-up exams for the duration of the study
- •Able and willing to provide written informed consent on the IRB (institutional review board)/IEC (institutional ethics committee)-approved Informed Consent form
- •Best spectacle corrected visual acuity of 20/80 or better in each eye.
- •Previously qualified for GC-009 clinical trial using the Travoprost Intraocular Implant with the travoprost intraocular implant (G2TR) that is present in the study eye.
排除标准
- •Glaucoma status as follows:
- •Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
- •Corneal status as follows:
- •Any active inflammation or edema
- •Any pathology for which, in the investigator's judgement, the following would be either at risk or contraindicated:
- •Implantation of Travoprost Intraocular Implant
- •Compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
- •Fellow eye status as follows:
- •Fellow eye actively enrolled in this trial or any other clinical trial
- •Subject status as follows:
- •Pregnant or planning to become pregnant during the course of the study
研究组 & 干预措施
Implantation and Exchange
Subjects will undergo implantation and exchange of a Travoprost Intraocular Implant through a small temporal clear corneal incision.
干预措施: Travoprost (Drug)
结局指标
主要结局
Ocular Safety
时间窗: 12 Months
Number of subjects with Adverse Events including intra-operative and post-operative events (TEAE's) in the study eye
次要结局
未报告次要终点