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NCT Number: NCT06351605

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

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Signs of active, inactive or history of exudative macular neovascularization (MNV)
  • History or active accumulation of intra and subretinal fluid of any cause (e.g., diabetic macular oedema, central serous retinopathy, cystoid macular oedema)
  • 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
  • Has any known photosensitivity to yellow light, red light, or near infrared radiation (NIR), or has a history of light activated CNS 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.

Treatment and study plan

Valeda Light Delivery System

Device

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.

Primary outcomes

  1. Best-Corrected Visual Acuity (BCVA)

    Time frame: 31 months

    Mean change from baseline in BCVA.

Secondary outcomes

  1. OCT Imaging

    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

  2. FAF Imaging

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Tedford, PhD

CONTACT

[email protected]

3605365122

Sponsors and collaborators

Lead sponsor

LumiThera, Inc.

Industry

Registry information

Official study title

A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation in Participants With Dry Age-Related Macular Degeneration (EUROLIGHT)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
Apr 8, 2024

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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