Home OCT-Guided Management of Neovascular Age Related Macular Degeneration: Outcomes and Insight After Switch to Faricimab for One Year
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Measure the efficacy of Home-OCT in the management of nvAMD treated with Faricimab.
研究概览
简要总结
Age-related macular degeneration (AMD) is a common eye disease that can lead to vision loss. The neovascular ("wet") form of AMD is usually treated with repeated injections into the eye. However, some patients do not respond well to their current treatment and need to switch to a different medication.
The purpose of this study is to evaluate whether using a home optical coherence tomography (Home OCT) device can improve the management of patients with neovascular AMD who are switching to faricimab treatment after an insufficient response to previous therapy. The Home OCT device allows participants to perform retinal scans at home several times a week. These scans are securely transmitted to the study team, allowing physicians to monitor changes in the retina more frequently than with routine clinic visits alone.
Participants will continue to receive the standard medical care determined by their treating retina specialist, including clinic visits, eye examinations, retinal imaging, and intravitreal injections. The Home OCT device will provide additional information to help detect changes in disease activity between clinic visits. If the scans suggest worsening of the condition, participants may be asked to return for an earlier evaluation.
The study aims to determine whether frequent home monitoring can identify treatment response sooner and support more personalized treatment decisions. The study will also collect information on the effectiveness of faricimab in routine clinical practice after switching from previous anti-VEGF therapy.
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
- •Patients at least 55 years of age.
- •Visual Acuity of 20/320 or better in the study eye.
- •Diagnosis of active nvAMD that was treated with at least 3 consecutive anti-VEGF injections.
- •Patients are meeting the standard care criteria to switch to a second line drug.
- •Patients are able and willing to conduct daily OCT self-imaging at home for the duration of the study.
- •Patient signing a consent form
排除标准
- •Patients with any other retinal disease in the study eye requiring steroidal or anti-VEGF injections (anti-VEGF injections during the study period must be for nvAMD).
- •Any concurrent ocular condition precluding acquisition of OCT images (eg, severe blepharoptosis, corneal opacification, cataract etc) in the study eye
研究组 & 干预措施
Home OCT Monitoring Cohort
Participants with neovascular age-related macular degeneration (nAMD) who are switching to faricimab after an inadequate response to previous anti-VEGF therapy. Participants will receive standard clinical care and perform home retinal monitoring using the Notal Vision Home OCT device at least four times per week for up to 12 months. Home OCT images will be reviewed by the study investigators to support disease monitoring and clinical decision-making.
干预措施: Home Optical Coherence Tomography (Home OCT) (Device)
结局指标
主要结局
Measure the efficacy of Home-OCT in the management of nvAMD treated with Faricimab.
时间窗: Up to 12 months
Time from the first faricimab injection to successful treatment response, defined by the investigator based on the ability to maintain disease control while extending treatment intervals, as assessed using Home OCT monitoring, clinical examination, and retinal imaging.
次要结局
- Faricimab Injection Interval(Up to 12 months)
- Number of Faricimab Injections(Up to 12 months)
研究者
Orly Gal-Or
Head of the Imaging Unit, Retina Specialist, Principle Investigator
Rabin Medical Center