Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT
报名条件（概要）
- 年龄：18 Years – 不限
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
研究药物 / 干预措施
Home-based Care Monitoring、Aflibercept 2Mg/0.05Ml Inj,Oph、Laser Treatment、Standard Hospital/clinic-based Care Monitoring
申办方
Zhongshan Ophthalmic Center, Sun Yat-sen University
研究简介（原文）
Diabetic macular edema (DME) is a common cause of central visual loss in diabetic patients and a global public health burden around the world. Most patients with DME and vision loss require pharmacological inhibition using anti-VEGF agents with multiple monitoring visits that require both visual acuity testing and optical coherence tomography (OCT) to determine if re-treatment is warranted as well as the recommended time interval to the next follow-up visit. However, this treatment regimen often requires monthly or every other month clinic visits, which places a substantial burden on ophthalmic clinics and patients. Recently, portable self-administered Home OCT devices have been developed that allow for home-based OCT scanning of retinal diseases, e.g., DME, although these devices do not include visual acuity determination. The investigators previously proposed to deliver Home OCT devices and Home visual acuity tester to patients\' homes to complete routine monitoring visits at home. However, there is a lack of evidence regarding the safety and efficacy of this novel monitoring regimen for DME patients, specifically whether its use could reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes. This study aims to provide evidence to support use of a novel monitoring regimen for DME patients that could substantially reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Yingfeng Zheng, MD, PhDzhyfeng@mail.sysu.edu.cn+8613922286455
- Zitian Liu, MD, PhDliuzt25@mail.sysu.edu.cn
中国／港澳台研究中心
- Dongguan Guangming Ophthalmic HospitalDongguan，Guangdong，China
- The Second Peoples Hospital of FoshanFoshan，Guangdong，China
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityGuangzhou，Guangdong，China
- The First Affiliated Hospital of Jinan UniversityGuangzhou，Guangdong，China
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT ClinicalTrials.gov Identifier: NCT06610747 Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University Investigational product: Home-based Care Monitoring, Aflibercept 2Mg/0.05Ml Inj,Oph, Laser Treatment, Standard Hospital/clinic-based Care Monitoring About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT 试验编号：NCT06610747 申办方：Zhongshan Ophthalmic Center, Sun Yat-sen University 研究药物：Home-based Care Monitoring、Aflibercept 2Mg/0.05Ml Inj,Oph、Laser Treatment、Standard Hospital/clinic-based Care Monitoring 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
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下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
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- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。