A Phase I Open Label Non-comparative Study Evaluating the Safety of a Single, Unilateral, Subretinal Administration of CNTO 2476 in Advanced Retinitis Pigmentosa
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 主要终点
- Level of anti-CNTO 2476 antibody in blood for immunogenicity testing
研究概览
简要总结
The main purpose of this study is to evaluate the preliminary safety and immunogenicity (ability of an antigen to provoke immune response in the human body) of CNTO 2476, administered subretinally, in participants with advanced retinitis pigmentosa (RP; disease of the eye that leads to loss of vision and blindness) with either light perception only (LP) or hand motion (HM).
详细描述
The study will be an open-label (all people know the identity of the intervention), first in human safety study. Nine adult men and women with advanced RP with LP only (first 5 participants) or not better than HM bilaterally (subsequent 4 participants) in both eyes will be enrolled. Participant 5 may have combination visual acuity of LP in the treated eye and no better than HM in the fellow eye. Treatment will proceed on a cohort basis ie, Cohort I: Participant 1; Cohort II: Participant 2; Cohort III: Participant 3 and 4; Cohort IV: Participant 5, 6, and 7; and Cohort V: Participant 8 and 9. The initial participants for each cohort must have completed at least 4 weeks of post-treatment follow-up before participants in the next cohort may be treated. There are 2 safety assessment phases in this study: the main phase approximately 12 months from the time the participant is eligible to enter the study and the long-term safety follow-up phase of 4 additional years. The total length of the participation in the study could last up to 5 years (including both the main and safety follow-up phases).
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
- •Confirmed diagnosis of retinitis pigmentosa that is not part of another systemic disease
- •Vision deficit characterized by vision that is not better than either light perception (Group 1) or hand motion (Group 2) in both eyes
- •Normal hematology and chemistry lab results
- •Participant is suitable candidate for ophthalmologic surgery
排除标准
- •Other significant ophthalmologic diseases or any other ophthalmologic condition that interferes with ophthalmologic examination
- •Women of childbearing potential
- •Ocular hypertension
- •Other serious medical conditions
研究组 & 干预措施
CNTO 2476
Participants 1 to 4: advanced retinitis pigmentosa (RP) with light perception only (LP); Participant 5: combination visual acuity of LP in the treated eye and no better than hand motion (HM) in the fellow eye; and Participants 6 to 9: advanced RP with hand motion (HM) will receive different dose levels of CNTO 2476.
干预措施: CNTO 2476 (Drug)
结局指标
主要结局
Level of anti-CNTO 2476 antibody in blood for immunogenicity testing
时间窗: Baseline, Days 7 and 15, Weeks 3 and 4, Months 2, 3, 6, 12, 24, 36, 48, and 60
Number of adverse events as a measure of safety and tolerability
时间窗: Up to 5 years from the time participant is eligible to enter study
次要结局
- Change from baseline in retinal structure and visual function(Up to 5 years from the time participant is eligible to enter study)