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A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (GLOBALIGHT)

Recruitingn/aAges any - anyAllLumiThera, Inc.
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In plain words

What the trial is, and whether it could suit you

The purpose of this registry study is to collect real life data pertaining to the safety and clinical effectiveness of multi-wavelength photobiomodulation (PBM) as provided by the Valeda Light Delivery System in participants with dry age-related macular degeneration (AMD) in routine clinical practice. Data will be collected retrospectively and prospectively. PBM involves the use of visible light to near infrared light (NIR) (500-1000 nanometers) produced by a laser or a non-coherent light source applied to the surface of the body to activate mitochondrial respiratory chain components, stabilize metabolic function, and promote cellular proliferation. This registry study will be conducted in Europe, the US, and select other countries approved by their regulatory agency. This registry study was initiated as a combined retrospective and prospective data collection effort. After the acquis

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosis or confirmation of diagnosis of dry AMD disease by Investigator; 2. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study; 3. Informed of the nature of this study and has provided written, informed consent; (participants enrolled retrospectively will need to be contacted and sign an informed consent form prior to their data being used). Exclusion Criteria: * US Sites Only: Center-involving geographic atrophy; * Neovascular maculopathy; * Use of any photosensitizing agent (e.g. topicals, injectables) activated by the Valeda Light Deliver System within 30 days prior to treatment without consulting participant's physician; * Known photosensitivity to yellow light, red light, or near infrared radiation (NIR), or has a history of light activated central nervous system disorders (e.g. epilepsy, migraine); * In the opinion of the Investigator, is unlikely to comply with the study protocol or has a history or current evidence of any condition that, in the opinion of the investigator, might interfere with the participant's involvement in the trial, or is not in the best interest of the participant.
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What it tests

  • Valedaยฎ Light Delivery System
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Where

6 sites
Retina Vitreous Associates Medical Group
Beverly Hills, United States
Cincinnati Eye Institute
Cincinnati, United States
Carolina Eyecare Physicians
Charleston, United States
Valley Retina Institute
McAllen, United States
Pacific Northwest Retina
Silverdale, United States
Institutt for Oyehelse
Oslo, Norway
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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