Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of ocular adverse events, including uncontrolled inflammation, endophthalmitis, and retinal tear/detachment, abnormal sensation in eye, conjunctival hyperemia, eye irritation, eye pain, eye pruritus, eye redness, headache, and iritis
研究概览
简要总结
This open-label, randomized, Phase II research study will look to see whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone.
详细描述
Age Related Macular Degeneration (AMD) is the leading cause of blindness in adults over the age of 50 years. It can cause permanent loss of eyesight due to deterioration of the macula.
Ranibizumab monotherapy is currently the standard of care in neovascular AMD patients. Inflammation is believed to play an important role in AMD. Currently, MD's are investigating modulating the inflammation component of AMD with intra-ocular steroids although there is a high rate of steroid associated adverse events, such as glaucoma, cataracts and endophthalmitis.
Bromfenac is a non-steroidal anti-inflammatory drug (NSAIDS) and is currently approved for the treatment of inflammation following cataract surgery. In combination with intravitreal ranibizumab, bromfenac may also provide anti-inflammatory effects and may be a safer alternative to steroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 50 years
- •Patients with active neovascular AMD
- •If the patient has bilateral disease and qualifies for the study, both eyes may be included
排除标准
- •Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception.
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Current or recent participation in another simultaneous investigational drug trial may be exclusionary at the investigator's discretion
- •Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
- •Previous intravitreal steroid or anti-VEGF therapy within last 3 months.
- •Patients with a concurrent corneal epithelial disruption or erosion
- •Patients with immune deficiencies that would affect the ability of the cornea to heal
- •Patients with a known sensitivity to any component of the formulations under investigation
研究组 & 干预措施
1
Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops
干预措施: combination ranibizumab + bromfenac (Drug)
2
ranibizumab injection alone.
干预措施: ranibizumab injection alone (Drug)
结局指标
主要结局
Assessment of ocular adverse events, including uncontrolled inflammation, endophthalmitis, and retinal tear/detachment, abnormal sensation in eye, conjunctival hyperemia, eye irritation, eye pain, eye pruritus, eye redness, headache, and iritis
时间窗: monthly
次要结局
- Mean change in visual acuity at 3, 6 and 12 months(every 3 months)