Une étude de registre pour évaluer la photobiomodulation dans la dégénérescence maculaire sèche liée à l'âge (EUROLIGHT) (EUROLIGHT)
Une étude de registre multicentrique pour évaluer la sécurité et l'efficacité de la photobiomodulation chez les participants atteints de dégénérescence maculaire sèche liée à l'âge (EUROLIGHT)
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 acquisition of LumiThera by Alcon Research, LLC in September 2025, the study was amended to prospectively collect data from U.S. sites starting in July 2026.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In this multi-center registry study, each qualifying eye will or will have been treated with the Valeda Light Delivery System for a total of nine short, non-invasive treatments over a three-to-five-week period and retreated every four to six months for a total of up to six rounds of treatment, as determined by the investigator.
Participants are considered to have completed the study if they complete at least one full treatment round with Optical Coherence Tomography (OCT) imaging collected post treatment. Participation may last up to 31 months, or as determined by the Investigator as the duration between treatment rounds and number of treatment rounds may vary by participant based on the progression of the disease as determined by the Investigator.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Alcon Call Center
- Numéro de téléphone: 1-888-451-3937
- E-mail: alcon.medinfo@alcon.com
Lieux d'étude
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Oslo, Norvège, 0366
- Actif, ne recrute pas
- Institutt for Oyehelse
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California
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Beverly Hills, California, États-Unis, 90211
- Pas encore de recrutement
- Retina Vitreous Associates Medical Group
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Ohio
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Cincinnati, Ohio, États-Unis, 45242
- Pas encore de recrutement
- Cincinnati Eye Institute
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South Carolina
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Charleston, South Carolina, États-Unis, 29414
- Pas encore de recrutement
- Carolina Eyecare Physicians
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Texas
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McAllen, Texas, États-Unis, 78503
- Recrutement
- Valley Retina Institute
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Washington
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Silverdale, Washington, États-Unis, 98383
- Pas encore de recrutement
- Pacific Northwest Retina
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The patient population for this study will consist of a target of at least 25 male and female participants per site of any ethnic background and with a diagnosis of dry AMD by the Investigator or confirmed by the Investigator. The participant must meet all the inclusion criteria, have none of the exclusion criteria, and give their written Informed Consent to participate in this clinical study.
Only if the participant is interested in participating, s/he would be given the option to sign the study consent and start the study procedures, or if retrospectively signing the informed consent form, have their data used in the study.
La description
Inclusion Criteria:
- Diagnosis or confirmation of diagnosis of dry AMD disease by Investigator;
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study;
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: OTHER
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Photobiomodulation (PBM)
Two alternating and sequential treatments with the Valeda Light Delivery System of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds, followed by 660 nm for 90 seconds, or a total of 180 seconds |
FDA-approved, multi-wavelength light delivery system for providing a pre-set treatment of pulsed light in 3 distinct wavelengths (PBM) to the participant's eye and retinal tissue through the open and closed eyelid. The Valeda Light Delivery System is a CE Marked Class IIa device in Europe (Certificate # CE 653115) and a Class 2 device in the United States (DEN230083). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Visual Acuity from Baseline at each Treatment Visit
Délai: Baseline (Day 0) pre-treatment; up to Month 31/exit
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Visual acuity will be assessed prior to any PBM treatment (baseline) and at each treatment visit after PBM was delivered. |
Baseline (Day 0) pre-treatment; up to Month 31/exit
|
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Number of Adverse Events Associated with PBM Treatment
Délai: Up to Month 31/exit
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The number of adverse events associated with PBM treatment will be reported. |
Up to Month 31/exit
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Sr. Principal Clinical Trial Operations, Surgical, Alcon Research, LLC
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CSP006
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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