A Phase 1b Multi-Center, Open-Label and Randomized Study of iSONEP (Sonepcizumab/LT1009) Administered as Intravitreous Injections to Subjects With PED Secondary to Exudative Age-Related Macular Degeneration or Polypoidal Choroidal Vasculopathy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Lpath, Inc.
- 入组人数
- 12
- 试验地点
- 5
- 主要终点
- To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP
研究概览
简要总结
LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).
详细描述
Sixteen (16) subjects per dose group who have received a minimum of 3 and no more than 7 doses of an anti-VEGF agent (i.e., Lucentis or Avastin), and whose PED has not decreased by greater than 25% in height despite therapy, will be enrolled for a total of 32 subjects. The presence of PED diagnosed by the Investigator will be confirmed by SDOCT, ICG and FA by a digital imaging reading center prior to subject enrollment. The ability of iSONEP to induce regression of persistent PED in subjects with exudative AMD or PCV despite previous treatment with an anti-VEGF agent will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females > 50 years of age with a diagnosis of PED secondary to AMD or PCV
- •Serous and/or fibrovascular PED secondary to exudative AMD or secondary to PCV (confirmed by SDOCT, FA and ICG) that has not demonstrated at least a 25% decrease in the height of the PED (from the onset of anti-VEGF therapy) following a minimum of 3 doses of an anti-VEGF agent (i.e., Lucentis or Avastin)
- •PED that has a height greater than 100 μm
- •Presence of CNV secondary to (i) AMD (based on FA) or (ii) PCV (based on ICG)
- •ETDRS BCVA of 20/32 to 20/320 (letter score of 73 to 25) in the study eye
- •ETDRS visual acuity of 20/400 or better in the fellow eye
排除标准
- •Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye
- •Subjects who have received < 3 and > 7 anti-VEGF treatments in the study eye
- •Subjects with retinal angiomatous proliferation (RAP lesion)
- •Lucentis or Avastin within 30 days prior to Day 1 in the study eye
研究组 & 干预措施
0.5 mg of iSONEP (sonepcizumab/LT1009)
iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate
干预措施: iSONEP (sonepcizumab/LT1009) (Drug)
2.0 mg of iSONEP (sonepcizumab/LT1009)
iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate
干预措施: iSONEP (sonepcizumab/LT1009) (Drug)
结局指标
主要结局
To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP
时间窗: 8 months
The number of participants with adverse events; changes in electrocardiogram parameters, diastolic and systolic blood pressure, pulse, temperature and intraocular pressure from baseline to the end of the study.
次要结局
- To evaluate various efficacy outcomes throughout the study(8 months)
- To evaluate the immunogenicity (antibody response) of iSONEP following multiple intravitreous injections(8 months)
- To characterize the systemic pharmacokinetic profile of iSONEP(8 months)