临床试验/NCT01177644

NCT01177644撤回1 期

Safety and Preliminary Efficacy Study of PDS-1.0 in Patients With Neovascular AMD

Forsight Vision40 个研究点开始时间: 2011年1月最近更新: 2012年8月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方
主要终点: Change in retinal thickness measured by Optical Coherence Tomography

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will evaluate the safety and preliminary effectiveness of PDS 1.0 in patients with neovascular AMD.

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: 50 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated
•Retinal thickness due to edema of at least 300um in the study eye
•Best corrected visual acuity of 20/80 or worse in the study eye
•Best corrected visual acuity of 20/40 or better in the fellow eye

排除标准

•Evidence of scarring CNV (e.g. geographic atrophy) in the study eye
•Fibrosis >75% of lesion area in the study eye

研究组 & 干预措施

Active

Experimental

干预措施: PDS 1.0 (Drug)

结局指标

主要结局

Change in retinal thickness measured by Optical Coherence Tomography

时间窗: Monthly

次要结局

Change in Best Corrected Visual Acuity(Monthly)

研究者

发起方

Forsight Vision4

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

1 期

Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)Age-Related Macular Degeneration

NCT01186432Forsight Vision420

Unknown

2 期

PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Subjects With Resectable Locally Advanced Thoracic Esophageal Squamous Cell CarcinomaEsophageal NeoplasmsEsophageal Squamous Cell Carcinoma

NCT05007145Fujian Cancer Hospital92

终止

1 期

First-in-human (FIH) Study of DS-1471a in Subjects with Advanced Solid Tumors

2024-517984-21-00Daiichi Sankyo Co. Ltd.17

招募中

1 期

The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's DiseaseEarly-onset Parkinson's Disease

NCT06608355iRegene Therapeutics Co., Ltd.6

已完成

1 期

Anti PD-1 Neo-adjuvant Treatment for NSCLCNon Small Cell Lung CarcinomaStage IStage II

NCT02938624Jair Bar, M.D., Ph.D.28