Oslo University Hospital
Oslo, Norway
Location status: Recruiting
NCT Number: NCT06351605
The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively.
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Observational
Oslo, Norway
Location status: Recruiting
This is a multi-center, retrospective and prospective registry study on the use of the Valeda® PBM system as a treatment for visual improvement in participants with dry AMD. The target is at least 25 participants/site in up to 20 participating sites in Europe.
Participants will or will have received nine non-invasive, short treatments over three to four weeks starting at Baseline (BL), with up to five additional rounds of treatment every four to six months, or as determined by the Investigator.
Standard visual outcome measurements collected will include visual acuity (either ETDRS BCVA or LogMAR) prior to and following treatment. OCT and Fundus Autofluorescence (FAF) imaging of the retina should be taken at screening, and after each round of treatment. As this is a registry study, missing
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Valeda Light Delivery System will deliver two alternating and sequential treatments of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds; and 660 nm for 90 seconds, or a total of 180 seconds.
Time frame: 31 months
Mean change from baseline in BCVA.
Time frame: 31 months
OCT instruments will be used to image the retina for diagnosis and anatomical assessments (general retinal thickness and drusen volume) of dry AMD pathology
Time frame: 31 months
FAF is used to evaluate both hypoautofluorescence (GA) and hyperauto-fluorescence and drusen byproducts, the deposition of lipofuscin in the retinal pigment epithelium D3001-CSP006 14MAY2023 V2.0 CONFIDENTIAL Page 22 of 42 (RPE).
Contact information is provided by the study sponsor or research team.
LumiThera, Inc.
Industry
A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation in Participants With Dry Age-Related Macular Degeneration (EUROLIGHT)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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