Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Number of injections
研究概览
简要总结
The purpose of this study is to implement quantitative assessment tools for the treatment of active neovascular AMD patients in a real-world setting in order to provide advantages for both patients (treatment burden) and healthcare system (scheduling visits/treatments).
详细描述
Neovascular age-related macular degeneration (nAMD) is a significant burden to health care systems in industrialized countries. Due to its chronic nature, continuous follow-up and treatment is needed to prevent significant loss of visual function in patients with nAMD.
Vascular endothelial growth factor (VEGF) plays a major role in the pathomechanisms of nAMD and large multicenter trials have shown that intravitreal application of substances which intercept the VEGF pathway can interrupt the progression of nAMD and improve the visual outcome.
As every single injection bears the risk of sight-threatening complications and increases the financial burden to health care providers, several studies have tested different treatment regimens, to decrease the number of applicated injections without compromising the gains in visual acuity. Thereby, strict protocols have been compared to flexible "as needed" regimens (pro re nata, PRN) and regimens with proactive increments of injection intervals (treat and extend, T&E).
Studies have indicated that the outcome of anti-VEGF treatment is better in standardized clinical trials than in so-called "real world settings". This is explained by tight exclusion criteria of sponsored trials, the shorter follow-up time and the small number of patients that are treated per center, resulting in a better standard of care.
PRN as well as T&E management showed disadvantages such as significant less vision gain in PRN and possible over treatment in T&E.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 - Quantitative
Patients will undergo monthly follow-up visits including fluid quantification and will be retreated in case of active disease, which is defined as:
- reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity compared to previous visit
- new sub-retinal hemorrhage
- increase >50% in IRF volume in the central 1 mm compared to month 2
- increase > 50 % in SRF volume in the central 1 mm compared to month 2
- in case of NO intra- and/or subretinal fluid (=less than 10nl) in visits 2 or 3, retreat if fluid in central 1mm ≥ 10nl
Presence/change of sub- and intraretinal fluid will be assessed objectively by AI software and the results will be provided during the visit to the investigator. The final decision for/against retreatment is always made by the discretion of the clinical investigator.
干预措施: anti-VEGF agent (Drug)
Cohort 2 - Qualitative
Patients will undergo monthly follow-up visits. Treatment will be performed in case of active disease, which is defined as:
- reduction of 5 EDTRS letters or more related to any (suspected) neovascular activity
- new sub-retinal hemorrhage
- any fluid
In this cohort the amount of retinal fluid will not be assessed by AI software at the time of retreatment.
干预措施: anti-VEGF agent (Drug)
结局指标
主要结局
Number of injections
时间窗: 12 months
Number of injections necessary within study period
次要结局
- Number of injections Best-corrected visual acuity (BCVA) assessed by ETDRS Score(12 months)
- Macular fluid volumes(12 months)
- Formation of geographic-like macular atrophy(12 months)
- Chorioretinal perfusion(12 months)
- Perfusion of the neovascular lesion(12 months)
- Central retinal thickness(12 months)
- Quality of Life by Questionnaire(12 months)
- Formation of retinal tears(12 months)
研究者
Stefan Sacu
Head of Vienna Clinical Trial Center, Dept. of Ophthalmology and Optometry
Medical University of Vienna