EUCTR2010-021291-29-CZ进行中（未招募）不适用
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 Twice Daily for the Treatment of Center-involving Clinically Significant Macular Edema Associated with Diabetic Retinopathy
适应症
试验速览
- 阶段
- 不适用
- 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.
- •7. Male patients with partners of childbearing potential must agree to
- •use at least one highly effective method of contraception throughout the
- •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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