EUCTR2017-005104-10-ES进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RO6867461 IN PATIENTS WITH DIABETIC MACULAR EDEMA (YOSEMITE) - YOSEMITE
Roche Farma S.A (Soc Uni) que realiza el ensayo en España y que actúa como representante de F.Hoffmann La-Roche Ltd0 个研究点目标入组 900 人开始时间: 2018年11月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
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
- •- Age >= 18 years
- •- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- •- Ability and willingness to undertake all scheduled visits and assessments
- •- For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 3 months after the final dose of study treatment
- •- Macular thickening secondary to DME involving the center of the fovea
- •- Documented BCVA of 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment
- •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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 360
排除标准
- •- Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
- •- Uncontrolled blood pressure
- •- Pregnancy or breastfeeding, or intention to become pregnant during the study
- •Ocular Exclusion Criteria for Study Eye
- •- Treatment with panretinal photocoagulation within 3 months prior to Day 1 to the study eye
- •- Macular laser within 3 months prior to Day 1 to the study eye
- •- Any IVT or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
- •- Any use of medicated intraocular implants, including Ozurdex®, within 6 months of Day 1 and Iluvien® implants at any time prior to Day 1 to the study eye
- •- Prior administration of IVT RO6867461 in either eye
- •- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- •- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- •- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
研究者
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