Russian Registry of Patients With Neovascular Age-Related Macular Degeneration (nAMD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2,665
- 试验地点
- 1
- 主要终点
- Percentage of patients with comorbidities and concomitant procedures and medications
研究概览
简要总结
A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry.
详细描述
The registry is a structured system which uses observational study methods for systematic collection of data on health condition in the specific patient population.
Real world clinical practice data will be collected. Patients will not undergo any additional examinations or procedures that are outside of the standard clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > to 18 years
- •Male or female patients diagnosed with nAMD (with or without previous treatment for nAMD including but not limited to PDT, laser coagulation, vitamins, retinolamine, emoxipine, anti-VEGF therapy or any surgery for nAMD).
- •Willing and able to provide informed written consent personally or by legal proxy
排除标准
- •The patient does not meet the inclusion criteria;
- •The patient is simultaneously participating in a different nAMD therapy study.
结局指标
主要结局
Percentage of patients with comorbidities and concomitant procedures and medications
时间窗: Baseline
Percentage of patients with systemic and ophthalmic comorbidities and percentage of patients with concomitant procedures and medications to be provided
Presence of macular atrophy
时间窗: Baseline, Up to 2 years
Presence of macular atrophy (with or without foveal involvement) (yes/no)
Number of patients by gender
时间窗: Baseline
Number of patients by gender to be provided
Age at the diagnosis
时间窗: Baseline
Age at the diagnosis to be provided
Patients with unilateral or bilateral disease
时间窗: Baseline
Percentage of patients with unilateral or bilateral disease
Time from diagnosis to entry to the registry
时间窗: Baseline
Mean time from diagnosis to entry to the registry to be presented
Visual acuity
时间窗: Baseline, up to 2 years
Changes in visual acuity assessed by Sivcev-Golovin's table (The table consists of two parts with 12 rows each, representing visual acuity values between 0.1 and 2.0.) or Snellen equivalent
Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment
时间窗: Baseline, Up to 2 years
Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment. (yes/no)
Central retinal thickness
时间窗: Baseline, Up to 2 years
Central retinal thickness to be measured with OCT (optical coherent tomography)
Fluid type
时间窗: Baseline, Up to 2 years
Type of the fluid assessed by optical coherence tomography and defined as follows: intraretinal fluid (IRF), subretinal fluid (SRF), fluid under repinal pigment epithelium (sub-RPE)
Indication for intravitreal anti-VEGF therapy
时间窗: Baseline, Up to 2 years
Indication for intravitreal anti-VEGF therapy to be collected
Social Characteristics (Working and Disability status)
时间窗: Baseline
Working status (number of patients that work/does not work, with age-related pension, disability pension). Disability status (number of patients established/not established, removed, disability group, whether AMD is the main reason for disability)
次要结局
- Time from diagnosis to the therapy initiation(Up to 2 years)
- Number of Optical coherence tomography (OCTs) done per year(Up to 2 years)
- Type of prescribed therapy(Up to 2 years)
- Percentage of patients with prescription of anti-VEGF drugs(Up to 2 years)
- Time from diagnosis to anti-VEGF injection(Up to 2 years)
- Number of visits per year(Up to 2 years)
- Number of anti-VEGF injections per year(Up to 2 years)
- Rate of treatment discontinuation(Up to 2 years)
- Reasons for treatment discontinuation(Up to 2 years)