NL-OMON53613已完成2 期
A First in Human trial to study safety and tolerability of single rising intravitreal doses (oPen label, non-randomized, uncontrolled) and in Addition the early biological Response of mulTiple intravitreal doses (double-masked, RandomIzed, shamcontrolleD) of BI 765128 in panretinal photocoaGulation (PRP) treated diabetic rEtinopathy (DR) patients with diabetic macular ischemia (DMI) - the PARTRIDGE Study - 1451-0001: PARTRIDGE study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Panretinal photocoagulation-treated DR patients with either no or inactive
- •retinal neovascularization per investigator judgement
- •Presence of significant DMI: Large foveal avascular zone (FAZ) defined as
- •those with >=0.5mm2 area present on OCTA. If FAZ is <0.5mm2 then an enlarged
- •peri-foveal inter-capillary space in at least 1 quadrant will be sufficient.
- •Best-corrected VA <=85 letters (20/20) in the study eye
排除标准
- •Diabetic Macular Edema (DME), defined as a CST >= 305µm for men and >= 290 µm
- •for women (Optovue Angiovue) in the study eye
- •Subjects receiving IVT injections for active DME (anti-VEGF, steroids) and
- •macular laser in the previous 3 months to screening in the study eye
- •History of vitrectomy in the study eye
研究者
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