An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 21
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
研究概览
简要总结
This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retinitis Pigmentosa in both eyes
- •Visual acuity between 20/40 to count fingers
排除标准
- •Growth of new blood vessels in the eye
- •Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
- •Any ocular disease that can interfere with diagnosis and or assessment of disease progression
- •Significant near-sightedness
- •Female patients who are pregnant, nursing, or planning pregnancy
研究组 & 干预措施
400 µg Brimonidine Tartrate Implant Group B
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
干预措施: 400 µg Brimonidine Tartrate Implant (Drug)
400 µg Brimonidine Tartrate Implant Group B
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
干预措施: Sham (no implant) (Other)
200 µg Brimonidine Tartrate Implant Group B
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
干预措施: 200 µg Brimonidine Tartrate Implant (Drug)
200 µg Brimonidine Tartrate Implant Group B
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
干预措施: Sham (no implant) (Other)
100 µg Brimonidine Tartrate Implant Group B
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
干预措施: 100 µg Brimonidine Tartrate Implant (Drug)
100 µg Brimonidine Tartrate Implant Group B
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
干预措施: Sham (no implant) (Other)
100 µg Brimonidine Tartrate Implant Group A
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
干预措施: 100 µg Brimonidine Tartrate Implant (Drug)
100 µg Brimonidine Tartrate Implant Group A
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
干预措施: Sham (no implant) (Other)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
时间窗: Baseline, Month 6
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
次要结局
- Change From Baseline in Contrast Sensitivity in the Study Eye(Baseline, Month 6)