Evaluation of Clinical Progression, Prognostic Factors, and Quality of Life in Patients with Age-related Macular Degeneration (VERA-nAMD).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Best-corrected visual acuity (BCVA)
研究概览
简要总结
The VERA-AMD study is a prospective, observational study designed to evaluate clinical progression, prognostic factors, and quality of life in patients with age-related macular degeneration (AMD). The study aims to analyze real-world clinical data to identify key predictors of disease progression and functional outcomes, with the goal of optimizing AMD management. The study involves 200 patients aged ≥50 with a confirmed diagnosis of AMD, monitored through routine clinical practice. Primary outcomes include progression rates to advanced AMD and changes in visual acuity, while secondary outcomes focus on retinal morphology and quality of life. Anti-VEGF therapy and AI-based fluid analysis will be integrated to explore their impact on disease progression and patient outcomes.
详细描述
The VERA-AMD study is a prospective, non-interventional, observational study investigating the clinical course, prognostic factors, and quality of life in patients with age-related macular degeneration (AMD). AMD is a leading cause of vision loss among the elderly, manifesting as either neovascular ("wet") AMD (nAMD) or geographic atrophy ("dry") AMD (GA-AMD). Despite advances in treatment, there is considerable variability in disease progression and response to therapy. This study aims to fill this gap by analyzing real-world data to identify predictors of disease progression and functional outcomes, ultimately improving clinical management strategies.
Study Objectives
The study's main objectives are to:
Assess the clinical progression of AMD in routine clinical practice. Identify prognostic factors associated with favorable or unfavorable disease outcomes.
Evaluate the impact of AMD on patient quality of life using validated questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 50 years.
- •confirmed diagnosis of AMD in at least one eye.
- •follow-up scheduled according to standard clinical practice.
排除标准
- •presence of other significant ocular conditions that could affect visual acuity.
- •systemic conditions that make the patient unsuitable for long-term follow-up.
结局指标
主要结局
Best-corrected visual acuity (BCVA)
时间窗: through study completion, 36 months
visual acuity measured as ETDRS letters
次要结局
- Fluid volume (nL) in the retinal compartments(through study completion, 36 months)
- central retinal thickness(through study completion, 36 months)
- Self-reported vision-targeted quality of life(through study completion, 36 months)
研究者
Daniele Veritti
Prof.
University of Udine