CTRI/2010/091/000257已完成2 期
A Multicenter, Masked, Randomized, Sham-Controlled, Parallel-Group, 3 Month Study with a 9-Month Safety Extension to Evaluate the Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS®) Applicator System in Improving Visual Function in Patients with a Previous Rhegmatogenous Macula-Off Retinal Detachment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
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
- •The macula-off retinal detachment must have been caused by a
- •rupture (rhegmatogenous in etiology)
- •- The repair of the macula-off retinal detachment must have
- •occurred at least 6 months before the Day 1 visit in the study eye
- •- The repair must have been deemed an anatomic success and
- •required no more than one macular re-attachment procedure
- •- The visual acuity score must be between 20/50 and 20/320 in the study eye
排除标准
- •- Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
- •- Anticipated need for ocular surgery during the 12-month study
- •- Any injectable, periocular, or intravitreal corticosteroid treatment
- •to study eye within 6 months prior to screening (eg, triamcinolone
- •- Any injectable, periocular, or intravitreal anti-VEGF treatment to
- •the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
- •- Any infectious condition in the study eye
研究者
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