A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 307
- 试验地点
- 15
- 主要终点
- Change From Baseline in Central Corneal Endothelial Cell Counts
研究概览
简要总结
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
详细描述
Many ocular diseases are characterized by oxidative stress and/or inflammation. Oxidative stress is also known to adversely impact corneal endothelial cells, and may be a factor resulting in the acute decrease in corneal endothelial cell density following ocular surgery. While corticosteroids provide potent anti-inflammatory efficacy in a wide range of acute and chronic inflammatory ocular diseases, their use is limited by their side effect profile, which includes the potential to elevate IOP and induce cataract formation. In addition, most available ophthalmic anti-inflammatory treatments, including corticosteroids, do not directly protect against the underlying oxidative stress component of the disease process. Consequently, there is a clinical need for agents that protect against oxidative stress and provide anti-inflammatory efficacy without inducing steroid-like side effects.
This study will assess the safety and efficacy of omaveloxolone (RTA 408) Ophthalmic Suspension (0.5% or 1%) versus vehicle for the prevention of corneal endothelial cell loss in patients undergoing cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female and ≥18 years of age and ≤80 years of age
- •Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
- •Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
- •Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
- •Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
- •Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit
- •Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart
排除标准
- •Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
- •Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
- •Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
- •Have an intraocular pressure (IOP) ≤5 mmHg in either eye
- •Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye
- •Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments
研究组 & 干预措施
Omaveloxolone Opthalmic Suspension 1%
A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
干预措施: Omaveloxolone Ophthalmic Suspension 1% (Drug)
Vehicle Ophthalmic Solution
A single drop of Vehicle Ophthalmic solution was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
干预措施: Vehicle Ophthalmic Solution (Drug)
Omaveloxolone Opthalmic Suspension 0.5%
A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery
干预措施: Omaveloxolone Ophthalmic Suspension 0.5% (Drug)
结局指标
主要结局
Change From Baseline in Central Corneal Endothelial Cell Counts
时间窗: 12 weeks
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
次要结局
- Percentage of Patients Who Were Pain Free 1 Day After Cataract Surgery(1 day)
- Percentage of Patients With Clinical Cure (Absence of Anterior Chamber Cells + Flare) at 2 Weeks After Cataract Surgery(2 weeks)
- Percentage of Patients With Absence of Anterior Chamber Flare at 2 Weeks After Cataract Surgery(2 weeks)
- Percentage of Patients With Absence of Anterior Chamber Cells at 2 Weeks After Cataract Surgery(2 weeks)
- Change From Baseline in Central Corneal Endothelial Cell Counts(6 weeks)