A real-world, prospective, multi-center, open-label, phase IV clinical study to evaluate the safety and effectiveness of intravitreal injections (IVI) of brolucizumab in patients with neovascular age-related macular degeneration (nAMD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 11
- 主要终点
- Incidence and characteristics of treatment-emergent adverse events
研究概览
简要总结
Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people affecting 10%-13% of individuals over the age of 65 in North America, Europe, and Australia . Genetic, environmental, and health factors play an important role in the pathogenesis of the disease.
The purpose of this study is to generate additional safety and effectiveness data in a larger nAMD patient population in India that more closely resembles the real-world population intended to be treated with brolucizumab.
A real-world, prospective, multi-center, open-label, phase IV clinical study to evaluate the safety and effectiveness of intravitreal injections (IVI) of brolucizumab in patients with neovascular age-related macular degeneration (nAMD)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Female or male, treatment naïve patient with ≥50 years of age, with neovascular age-related macular degeneration (nAMD).
- •Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.
- •Note: In case where both eyes are affected, data of only one eye [‘study eye’] will be recorded.
- •selection of the eye to be considered for the purpose of the study [referred to as ‘study eye’] will be as per the Investigator’s discretion.
排除标准
- •Patient having other eye diseases that could compromise the visual acuity (VA).
- •Patient with existing or suspected ocular or periocular infection in the study eye.
- •Patient with an existing intraocular inflammation (IOI).
- •Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator’s judgment.
- •Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study.
- •Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
结局指标
主要结局
Incidence and characteristics of treatment-emergent adverse events
时间窗: baseline to Week 56.
次要结局
- To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA)(baseline to Week 56.)
- Characterize the number of anti-VEGF injections, number of non-injection visits, and total number of visits(baseline to Week 56.)
- Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w(baseline to Week 56.)
- Estimate effect of brolucizumab on fluid(baseline to week 16 and week 56.)
- Estimate effect of brolucizumab on central subfield thickness (CST)(baseline to week 16 and week 56.)