NCT01327911已完成1 期
A Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients With Macular Telangiectasia Type 2 (Mactel)
Neurotech Pharmaceuticals4 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2011年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Visual Acuity
研究概览
简要总结
This study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of NT-501 implants in 5-7 study participants with Mactel.
详细描述
Protocol for Extended Follow-up of a Phase 1 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotrophic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel)
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must be offered sufficient opportunity to review the informed consent form, agree to the form's contents and sign the protocol's informed consent;
- •The participant must have bilateral MacTel;
- •Women of childbearing potential and all men must agree to use an effective form of birth control during the study;
- •Participant must be medically able to undergo ophthalmic surgery for ECT implant;
- •The participant's best-corrected visual acuity 64 letters or better (20/50 or better) in the study eye;
排除标准
- •Participant is < 21 years of age;
- •Participant is medically unable to comply with study procedures or follow- up visits;
- •Participant has evidence of ocular disease other than MacTel that may confound the outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis, etc.);
- •Participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease, that in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted);
- •Participant has evidence of subretinal neovascularization in either eye;
- •Participant has evidence of central serous chorio-retinopathy (CSR) in either eye;
- •Participant has evidence of pathologic myopia in either eye;
- •Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty;
结局指标
主要结局
Visual Acuity
时间窗: 3,12, 24 and 36 months
Visual acuity decrease of \>=15 letters
次要结局
- OCT(12, 24, and 36 months)
- Microperimetry(12, 24 and 36 months)
研究者
研究点 (4)
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