A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 19
- 主要终点
- Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)
研究概览
简要总结
This study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the NT-501 implants in participants with Mactel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent
- •Participant must have at least one study eye with a positive diagnosis of MacTel Type 2
- •Participant must have an IS/OS PR break in the study eye(s) and en face ellipsoid zone (area of IS/OS loss) as measured by SDOCT between 0.16 mm2 and 4.00 mm2
- •If female, participant must be incapable of pregnancy
- •If male, participant must agree to use an effective form of birth control during the study
排除标准
- •Participant is unable to provide informed consent
- •Participant is less than 21 years of age or greater than 80 years of age
- •Participant is medically unable to comply with study procedures or follow-up visits
- •Participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months
- •Participant is pregnant or breastfeeding
研究组 & 干预措施
NT-501 Implant procedure
The investigational product is the NT-501 encapsulated cell system which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that were derived from the NTC-200 cell line by genetic modification so as to secrete recombinant human ciliary neurotrophic factor (CNTF).
干预措施: Ciliary neurotrophic factor (CNTF) (Biological)
NT-501 Implant procedure
The investigational product is the NT-501 encapsulated cell system which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that were derived from the NTC-200 cell line by genetic modification so as to secrete recombinant human ciliary neurotrophic factor (CNTF).
干预措施: NT-501 Implant procedure (Procedure)
Sham procedure
Non-penetrating sham procedure to mimic implant procedure
干预措施: Sham procedure (Procedure)
NT-501 Implant procedure
The investigational product is the NT-501 encapsulated cell system which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that were derived from the NTC-200 cell line by genetic modification so as to secrete recombinant human ciliary neurotrophic factor (CNTF).
干预措施: NT-501 Implant (Device)
结局指标
主要结局
Ellipsoid zone (area of IS/OS loss) as measured by en face imagining by SDOCT in study eye(s)
时间窗: 24 months
Change in the ellipsoid zone (area of IS/OS loss) from baseline to month 24 as measured by en face imaging by SDOCT in study eye(s)
次要结局
- Reading Speed(12 and 24 Months)
- Ellipsoid zone(12 months)
- Retinal sensitivity (dB) as measured by microperimetry(12 and 24 months)
- Increase in ellipsoid zone(12 and 24 months)
- Visual Acuity(12 and 24 Months)