Registry to assess light therapy for dry age-related macular degeneration
A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation in Participants With Dry Age-Related Macular Degeneration (EUROLIGHT)
This study is testing if a new light therapy can safely help people with dry age-related macular degeneration see better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | LumiThera, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06351605 on ClinicalTrials.gov |
What this trial studies
The EUROLIGHT study is a multi-center registry that aims to gather real-world data on the safety and effectiveness of the Valeda® photobiomodulation (PBM) system for treating dry age-related macular degeneration (AMD). Participants will receive a series of non-invasive light treatments over a period of three to four weeks, with the possibility of additional treatments every few months. Visual outcomes will be measured using standard assessments such as visual acuity and imaging techniques like OCT and Fundus Autofluorescence. The study will include both retrospective and prospective data collection from up to 20 sites across Europe.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with dry age-related macular degeneration who can comply with study requirements.
Not a fit: Patients with active or history of exudative macular neovascularization or those with certain retinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new non-invasive treatment option for patients with dry age-related macular degeneration, potentially improving their vision.
How similar studies have performed: While this approach is being evaluated in this registry, similar studies using photobiomodulation have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Stephanie Tedford, PhD
- Email: setedford@lumithera.com
- Phone: 3605365122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.