NCT07607496招募中不适用
Individualized Navigated Photothermal Therapy in Patients With Intermediate AMD: A Randomized, Double-Blinded, Controlled Clinical Trial to Evaluate the Performance of theTherapy Proposed by Macula Explorer Using Navilas Laser System
OD-OS MacuTherm GmbH10 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年5月29日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 10
研究概览
简要总结
The goal of this study is to demonstrate that photothermal therapy with the individually dosed treatment plan proposed by Macula Explorer delivered safely by Navilas® Laser System effectively improves the life of photoreceptors and reduces the progression of intermediate Age-related Macular Degeneration (iAMD) and preserves photoreceptors shown by Ellipsoid Zone Integrity (EZI).
Participants will be randomized to either Treatment or Control Group. There will be 12 visits, monthly for the first 3 months, then quarterly until the end of the study after 2 years.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male, female, or diverse
- •Age of 60 to 90 years old
- •Clinically confirmed intermediate AMD (iAMD, AREDS category 3) with the presence of:
- •At least 3 large drusen (diameter > 125 μm) within the inner ring of 3mm diameter of the ETDRS Grid centered on the fovea (with or without reticular pseudodrusen (RPE))
- •combined with at least 1 of the following other signs:
- •Incomplete RPE and outer retinal atrophy (i-RORA) outside central 1mm ring and/or
- •Hyperreflective foci (HRF) adjacent to drusen (within 3 mm)
- •Best corrected visual acuity between 65 and 87 letters
- •Clear optic media
- •Ability to communicate clearly and to understand and comply with the nature and requirements of the study
- •Ability to provide written informed consent in accordance with institutional, local and national regulatory guidelines
- •Willing to participate
排除标准
- •Presence of late-stage AMD, neovascular (nAMD, active or fibrotic) or geographic atrophy (GA)
- •Maculopathies showing only pseudodrusen
- •Any systemic medication known to be toxic to the lens, retina or optic nerve
- •Any intraocular surgery within 6 months prior to study inclusion (except uncomplicated cataract surgery > 3 months)
- •Any previous thermal laser treatment in the macula
- •History of vitrectomy, filter surgery, corneal transplantation or retinal detachment
- •Previous therapeutic radiotherapy in the eye region
- •Pregnant or breast-feeding patients
- •Participation in an investigational drug, biologic or device study within 6 months prior to study entry (Note: observational clinical studies involving only over-the-counter vitamins, supplements or diets are not excluded)
- •Expected participation in an investigational drug, biologic or device study during the duration of this clinical investigation except clinical investigations for diagnostic purposes where examinations are not influencing the outcome of the current clinical investigation. Mandatory for participation in this additional clinical investigation is prior approval from the sponsor of this clinical investigation in writing
- •A serious medical condition that prevents the patient from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinological, neurological or haematological conditions) or, in the opinion of the investigator, is likely to require surgery or hospitalization (at any time during his/her participation on this clinical investigation)
- •Known allergy to any ingredient required (for dilation of the pupil, if no alternative agent may be applied) or any contraindication to be treated with Navilas® Laser System 577SL
- •If, in the opinion of the investigator, it is unlikely that the study protocol will be followed
- •If only one eye is eligible for inclusion, none of the following criteria must be present in the fellow eye in order to allow inclusion of the study eye:
- •Presence of late-stage AMD in need of therapy
- •Presence of neovascular AMD (nAMD) in need of therapy
- •Presence of geographic atrophy (GA) in need of therapy (e.g. complement-inhibitors)
- •All the non-AMD eye diseases mentioned for the study eye as exclusion criteria
- •Previous therapeutic radiotherapy in the fellow eye region
研究组 & 干预措施
Treatment Group
Experimental
干预措施: photothermal therapy (Device)
Control Group
Sham Comparator
干预措施: Sham treatment (Device)
研究者
研究点 (10)
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