Protocol PVD-202: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD in Non-Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 12
- 主要终点
- Observation of pharmacologic induction of PVD.
研究概览
简要总结
A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-Proliferative Diabetic Retinopathy Subjects of any grade
- •Subjects with either a) no PVD, b) stage 1 PVD or c) stage 2 PVD at baseline by b-scan in the study eye
- •Subjects that are at least 45 years of age
- •Subjects that are free of other significant retinal pathologies that could interfere with the measurements or conduct of this study
- •Intraocular Pressure under control, IOP 30 mm or less
- •Male or female subjects
- •Signed Informed Consent -
排除标准
- •No media opacities or abnormalities that would preclude observation of the retina or performance of any study related imaging tests
- •History of prior vitrectomy in the study eye
- •Subjects with epiretinal membranes, vitreomacular adhesion, vitreomacular traction, or macular holes in the study eye at baseline
- •Subjects with proliferative DR, neovascular AMD, or retinal vascular occlusion in the study eye
- •Subjects with clinically significant macular edema in the study eye
- •Subjects with a history of focal/grid or pan-retinal laser photocoagulation in the study eye
- •Subjects likely to need intraocular surgery, laser treatment, or non-study intravitreal injections in the study eye during the study period.
- •Subjects with history of retinal detachment in the study eye
- •High myopes with a spherical equivalent of > -8.00 D spectacle correction in the study eye
- •Subjects with systolic BP> 180 at screening
- •Subjects with HgA1c >12.0 within 90 days preceding enrollment
- •Subjects that have chronic or recurrent uveitis
- •Subjects that have ongoing ocular infection or inflammation
- •Subjects with uncontrolled glaucoma, ie IOP > 25mm with or without IOP lowering agents
- •Subjects that have contraindications to the study medication
- •Subjects who are unable to meet the extensive post-op evaluation regimen
- •Pregnant or nursing women
- •Subjects with a history of penetrating ocular trauma in the study eye
- •Subjects that are participating in another clinical research study
研究组 & 干预措施
1.0mg Luminate®
1.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
干预措施: 1.0mg Luminate® (Drug)
2.0mg Luminate®
2.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
干预措施: 2.0mg Luminate® (Drug)
3.0mg Luminate®
3.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
干预措施: 3.0mg Luminate® (Drug)
Balanced Salt Solution 0.10cc
Balanced Salt Solution 0.10cc injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
干预措施: Balanced Salt Solution for intravitreal injection in 0.10cc (Other)
结局指标
主要结局
Observation of pharmacologic induction of PVD.
时间窗: 90 days
The primary endpoint of this study is observation of pharmacologic induction of at least a stage 3 PVD, with PVD defined as a complete PVD to the equator except for vitreopapillary adhesion as seen on B-scan Ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center.
次要结局
- The secondary endpoints of this study is the observation of a complete stage 4 PVD to the equator including vitreopapillary release as seen by B-scan ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center.(90 days)