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

NCT ID: NCT06351605

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

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

Conditions

Dry Age-related Macular Degeneration

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

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.

Valeda Light Delivery System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis or confirmation of diagnosis of dry AMD disease by Investigator

2. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study

3. 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

1. Signs of active, inactive or history of exudative macular neovascularization (MNV)

2. History or active accumulation of intra and subretinal fluid of any cause (e.g., diabetic macular oedema, central serous retinopathy, cystoid macular oedema)

3. 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

4. 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)

5. 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LumiThera, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy Croissant, MBA

Role: STUDY_DIRECTOR

LumiThera, Inc.

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Stephanie Tedford, PhD

Role: CONTACT

setedford@lumithera.com

3605365122

Facility Contacts

Øygunn Utheim, MD

Role: primary

outheim@gmail.com

+47 93692578

Other Identifiers

CSP006

Identifier Type: -

Identifier Source: org_study_id