EUCTR2010-021291-29-BE进行中（未招募）1 期
A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 TwiceDaily for the Treatment of Center-involving Clinically Significant Macular Edema Associated with Diabetic Retinopathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 261
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, at least 18 years of age
- •2. Written, signed informed consent obtained
- •3. Diagnosis of diabetes mellitus
- •4. Clinically significant diabetic macular edema in at least one eye (study eye”) involving the center of the macula.
- •5. Mild to severe non proliferative diabetic retinopathy
- •6. Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study.
- •9. Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 183
排除标准
- •1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity (including but not limited to severe macular ischemia, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition)
研究者
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