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

NCT06351605 | Recruiting

• 1 other identifier: CSP006
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Best-Corrected Visual Acuity (BCVA)

  Mean change from baseline in BCVA.

  31 months

Secondary Outcomes (2)

• OCT Imaging

  31 months

• FAF Imaging

  31 months

Study Arms (1)

Photobiomodulation (PBM)

Valeda Light Delivery System 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.

Device: Valeda Light Delivery System

Interventions

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.

Photobiomodulation (PBM)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• LumiThera, Inc.: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Study Officials

• Cindy Croissant, MBA

  LumiThera, Inc.

  STUDY DIRECTOR

Central Study Contacts

Stephanie Tedford, PhD

CONTACT

3605365122; setedford@lumithera.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

NO (1)