NCT00320814已完成1 期
An Exploratory Study of the Safety, Tolerability and Biological Effect of a Single Intravitreal Administration of VEGF Trap in Patients With Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- To assess the ocular and systemic safety and tolerability of a single intravitreal (IVT) injection of VEGF Trap-Eye in patients with diabetic macular edema (DME)
研究概览
简要总结
To assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with diabetic macular edema.
详细描述
This is an open label study. Initially, 5 patients with DME will receive an ITV injection of VEGF Trap into the study eye. Additional patients may be enrolled at the same or additional dose levels. Patients will be observed for six weeks following the injection for assessments of ocular and systemic safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Diagnosis of diabetes mellitus (type 1 or type 2).
- •Best corrected E-ETDRS visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤ 73 letters (i.e., 20/40 or worse).
- •On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
- •Retinal Thickness at the center point ≥ 250 microns.
- •Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
排除标准
- •History of any vitreous hemorrhage within 4 weeks prior to Visit 2 (Day 1).
- •Macular edema due to causes other than diabetic macular edema. An eye should be considered ineligible: (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular edema.
- •An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
- •An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.).
- •Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase 1 study.
研究组 & 干预措施
VEGF Trap-Eye
Experimental
single IVT injection of 4.0 mg of VEGF Trap-Eye into the study eye on Day 1
干预措施: VEGF Trap-Eye (Drug)
结局指标
主要结局
To assess the ocular and systemic safety and tolerability of a single intravitreal (IVT) injection of VEGF Trap-Eye in patients with diabetic macular edema (DME)
时间窗: Assessments for safety and tolerablity are performed at each visit (Visit 1 - Visit 10)
次要结局
- To obtain a preliminary assessment of the effect of a single dose of VEGF Trap-Eye on central retinal thickness (CRT) at the center point as determined by optical coherence tomography (OCT)(Assessments for CRT are performed at each visit (Visit 1 - Visit 10) by means of OCT.)
- To obtain a preliminary assessment of the effect of a single IVT administration of VEGF Trap-Eye on visual acuity(Assessments for visual acuity are performed at each visit (Visit 1 - Visit 10).)
研究者
相似试验
已完成
1 期
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMDNeovascular Age Related Macular DegenerationNCT00383370Regeneron Pharmaceuticals20
撤回
2 期
Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP)Retinopathy of PrematurityNCT01232777Vision Research Foundation
已完成
3 期
Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)Macular EdemaNCT01512966Bayer73
已完成
3 期
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central InvolvementMacular EdemaNCT01783886Bayer381
已完成
3 期
Intravitreal Aflibercept Injection in Vision Impairment Due to DMEDiabetes MellitusMacular EdemaNCT01331681Bayer406