En registerstudie för att bedöma fotobiomodulering vid torr åldersrelaterad makuladegeneration (EUROLIGHT) (EUROLIGHT)
En multicenter-registerstudie för att bedöma säkerheten och effektiviteten av fotobiomodulering hos deltagare med torr åldersrelaterad makuladegeneration (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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Alcon Call Center
- Telefonnummer: 1-888-451-3937
- E-post: alcon.medinfo@alcon.com
Studieorter
-
-
California
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Beverly Hills, California, Förenta staterna, 90211
- Har inte rekryterat ännu
- Retina Vitreous Associates Medical Group
-
-
Ohio
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Cincinnati, Ohio, Förenta staterna, 45242
- Har inte rekryterat ännu
- Cincinnati Eye Institute
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29414
- Har inte rekryterat ännu
- Carolina Eyecare Physicians
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-
Texas
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McAllen, Texas, Förenta staterna, 78503
- Rekrytering
- Valley Retina Institute
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Washington
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Silverdale, Washington, Förenta staterna, 98383
- Har inte rekryterat ännu
- Pacific Northwest Retina
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-
-
-
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Oslo, Norge, 0366
- Aktiv, inte rekryterande
- Institutt for Oyehelse
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiv: OTHER
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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). |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Visual Acuity from Baseline at each Treatment Visit
Tidsram: Baseline (Day 0) pre-treatment; up to Month 31/exit
|
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
|
|
Number of Adverse Events Associated with PBM Treatment
Tidsram: Up to Month 31/exit
|
The number of adverse events associated with PBM treatment will be reported. |
Up to Month 31/exit
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Sr. Principal Clinical Trial Operations, Surgical, Alcon Research, LLC
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CSP006
Plan för individuella deltagardata (IPD)
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