CTRI/2024/02/062287尚未招募3 期
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study To Investigate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of RO7200220 Administered Intravitreally In Patients With Uveitic Macular Edema
F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1. Diagnosis of non infectious uveitis (NIU) of any anatomical type (anterior, intermediate, posterior, panuveitis)
- •2. Active and inactive NIU is allowed.
- •3. Macular edema due to NIU defined as CST more than equal to 325 um on Spectralis SD-OCT or more than equal 315 um on Topcon or Cirrus at screening evaluated by CRC
- •4. BCVA letter score of 73 to 19 letters (both inclusive) on ETDRS-like charts (20 OR 40 to 20 OR 400 Snellen equivalent) at Day 1
排除标准
- •1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •2. Evidence of active or latent syphilis infection
- •3. Evidence of active or latent tuberculosis infection, or previous or current HIV diagnosis
- •4. Serious acute or chronic medical illness
- •5. Blood transfusion within 12 months prior to screening
- •6. Any major non-ocular surgical procedure within 1 month prior to Day 1
- •7.Any febrile illness within 1 week prior to Day 1
- •8. Any known hypersensitivity to fluorescein, dilating eye drops, or topical anesthetic eye drops
研究者
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