Extension Study of NT-501 Ciliary Neurotrophic Factor (CNTF) Implant for Macular Telangiectasia (MacTel)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 11
- 主要终点
- Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
研究概览
简要总结
This was a prospective, multicenter, single-masked, sham-controlled extension study designed to provide long-term safety and efficacy follow-up data for subjects with MacTel who had NT-501 implanted intraocularly and/or underwent sham surgery in the respective precursor study (NTMT-01 or NTMT-02).
A substudy was conducted in which subjects enrolled in study (NTMT-02), who had 1 study-eligible eye that underwent sham surgery, were offered the option to have NT-501 implanted in the same study eye. Of the 19 subjects who had 1 study-eligible eye and underwent sham surgery in the Cohort 2 precursor study (NTMT-02), 16 subjects elected to have NT-501 implanted in the same study eye during the substudy
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
- Single (Outcomes Assessor)
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
- •Previously enrolled in the NTMT-01 or NTMT-02 protocol and received the NT-501 implant and/or underwent a Sham procedure
- •Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents, and provide written informed consent.
排除标准
- •There are no Exclusion Criteria
研究组 & 干预措施
Cohort 1
Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF).
干预措施: Ciliary neurotrophic factor (CNTF) (Biological)
Cohort 1
Participants completed protocol NTMT-01. All participants received surgery to implant NT-501. All participants received ciliary neurotrophic factor (CNTF).
干预措施: Surgery (Procedure)
Cohort 2
Participants completed protocol NTMT-02. Participants for cohort 2 arm were either:
- NT-501 group: included subjects who each had 1 study-eligible eye that had NT-501 implanted and a fellow eye that did not undergo any study intervention.
- Sham group: included subjects who each had 1 study-eligible eye that underwent sham surgery and a fellow eye that did not undergo any study intervention.
- Sham+NT-501 group: included subjects who had both eyes that were study-eligible, and had NT-501 implanted in 1 eye and underwent sham surgery in the contralateral eye.
干预措施: Ciliary neurotrophic factor (CNTF) (Biological)
Cohort 2
Participants completed protocol NTMT-02. Participants for cohort 2 arm were either:
- NT-501 group: included subjects who each had 1 study-eligible eye that had NT-501 implanted and a fellow eye that did not undergo any study intervention.
- Sham group: included subjects who each had 1 study-eligible eye that underwent sham surgery and a fellow eye that did not undergo any study intervention.
- Sham+NT-501 group: included subjects who had both eyes that were study-eligible, and had NT-501 implanted in 1 eye and underwent sham surgery in the contralateral eye.
干预措施: Surgery (Procedure)
结局指标
主要结局
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 1
时间窗: 72, 84, 96, and 108 months (based on participants' original implant date during precursor study)
Change from baseline to 72, 84, 96 and 108 months post-surgery (based on participants' original implant date during precursor study) by SD-OCT for Cohort 1
Ellipsoid Zone (Area of IS/OS Loss) - Cohort 2
时间窗: Baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study)
Change in EZ from baseline to 36, 48, 60 and 72 Months post-surgery (based on participants' original implant date during precursor study). Cohort 2 sham surgery arm includes 16 participants (16 eyes) that received an NT-501 following their Month 36 follow-up
次要结局
- Change in Retinal Sensitivity (dB) From Baseline - Cohort 2 Only(Baseline to 72 Months (based on participants' original implant date))
- Change in BCVA From Baseline for Cohort 1(Baseline to 108 Months (based on participants' original implant date))
- Change in BCVA From Baseline for Cohort 2(Baseline to 72 Months (based on participants' original implant date))
- Change in Reading Speed From Baseline - Cohort 2 Only(Baseline to 72 Months (based on participants' original implant date))