NCT02681809终止2 期
A Phase 2, Randomised, Double Masked, Sham Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total Posterior Vitreous Detachment (PVD) in Subjects With Non-proliferative Diabetic Retinopathy (NPDR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 48
- 主要终点
- Number of Subjects With Total PVD by the Month 3 Visit
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or older
- •Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
- •HbA1c ≤ 12%, as assessed by the central laboratory
- •Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field stereo colour fundus photograph
- •Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic macular oedema
- •No evidence of total PVD in the study eye
- •Written informed consent obtained from the subject prior to screening procedures
排除标准
- •History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR
- •Presence of epiretinal membrane in the study eye
- •Presence of foveal ischemia in the study eye
- •Presence of pre-retinal or vitreous haemorrhage in the study eye
- •Presence of iris or angle neovascularisation in the study eye
- •Any active ocular / intraocular infection or inflammation in either eye
- •Aphakic study eye
- •Uncontrolled hypertension in the opinion of the Investigator
- •Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens / zonular instability
研究组 & 干预措施
Ocriplasmin 0.0625mg
Experimental
干预措施: ocriplasmin 0.0625mg (Drug)
Ocriplasmin 0.125mg
Experimental
干预措施: ocriplasmin 0.125mg (Drug)
Sham injection
Sham Comparator
干预措施: Sham injection (Drug)
结局指标
主要结局
Number of Subjects With Total PVD by the Month 3 Visit
时间窗: Month 3
Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres
次要结局
- Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye(From first injection until the end of the study (Month 24))
研究者
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