MacuTherm Performance Study in Patients With iAMD
2026年8月10日 更新者：OD-OS MacuTherm GmbH
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
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.
研究概览
研究类型
介入性
注册 (估计的)
240
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jan Tode, Prof. Dr. med.
- 电话号码：+49 3328 31 282-100
- 邮箱：Jan.Tode@od-os.com
学习地点
-
-
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Detmold、德国、32756
- 招聘中
- Gemeinschaftspraxis GbR Dr. Giers, Dr. Faßbender & Partner
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接触：
- Jana Riedl, Dr. med.
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Hanover、德国、30625
- 尚未招聘
- Department of Ophthalmology at Hannover Medical School
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接触：
- Maximilian LJ Hamann, Dr. med.
- 电话号码：+49 (511) 532-2379
- 邮箱：hamann.max@mh-hannover.de
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Lübeck、德国、23538
- 招聘中
- Department of Ophthalmology, University Medical Center Schleswig-Holstein
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接触：
- Miura Yoko, Prof. Dr. med.
- 电话号码：+49 451 3101 3212
- 邮箱：yoko.miura@uni-luebeck.de
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Mannheim、德国、68167
- 招聘中
- Augenklinik Universitätsmedizin Mannheim, Department Augenheilkunde
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接触：
- Robert Finger, Prof. Dr. Dr. med.
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Münster、德国、48145
- 招聘中
- Augenklinik am St. Franziskus-Hospital Münster
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接触：
- Georg Spital, Dr. med.
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Potsdam、德国、14467
- 招聘中
- Potsdam Eye Clinic at Gräfehaus
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接触：
- Volker Rasch, Dr. med.
- 电话号码：+49 331 280860
- 邮箱：macutherm@graefe-haus.de
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Schleswig、德国、24837
- 招聘中
- AugenNord Medical Practice and Surgical Center
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接触：
- Imke Biedermann, Dr. med.
- 电话号码：+49 4351 72 75 0
- 邮箱：macutherm@augennord.de
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Trier、德国、54296
- 招聘中
- MVZ Augenklinik Petrisberg GmbH, Klinik und Praxis für Augenheilkunde
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接触：
- Kai Januschowski, Prof. Dr. med.
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Zschopau、德国、09405
- 招聘中
- Praxis Zschopau I
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接触：
- Simo Murovski, Dr. med.
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Key Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
假比较器：控制组
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Patients receive sham treatment in the study eye
|
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实验性的：治疗组
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Patients receive individualized photothermal therapy in the study eye
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary endpoint is defined by preservation of Ellipsoid Zone Integrity (EZI).
大体时间：12 months
|
It is reached if at 12 months the EZI change from baseline is significantly better in the Treatment Group than in the Control Group.
|
12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in eyes of Treatment Group compared to eyes in Control Group compared to baseline to determine progression of Drusen within ETDRS sector (<6mm)
大体时间：24 months
|
24 months
|
|
Rate of eyes converting to geographic atrophy
大体时间：24 months
|
24 months
|
|
Rate of eyes converting to active exudative nAMD
大体时间：24 months
|
24 months
|
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Loss in BCVA of > 3 lines compared to baseline
大体时间：24 months
|
24 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jan Tode, Prof. Dr. med.、OD-OS MacuTherm GmbH
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月29日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年5月13日
首先提交符合 QC 标准的
2026年5月20日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年8月11日
上次提交的符合 QC 标准的更新
2026年8月10日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
It is not planned to share individual participant data.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.