Actively Recruiting
A Multi-Center Registry Study to Assess the Safety and Effectiveness of Photobiomodulation in Participants With Dry Age-Related Macular Degeneration (EUROLIGHT)
Led by LumiThera, Inc. · Updated on 2024-04-08
500
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing the safety and effectiveness of photobiomodulation (PBM) treatment for people with dry age-related macular degeneration (dry AMD) through the EUROLIGHT study. This multi-center registry study collects real-life data from routine clinical practice, including both retrospective and prospective participants, aiming to improve vision in those affected by dry AMD. Participants will receive treatment using the Valeda Light Delivery System, which delivers specific light wavelengths (590 nm, 850 nm, and 660 nm) in short sessions. Each participant will undergo nine non-invasive treatments over three to four weeks starting at baseline. Additional treatment rounds of up to five cycles may be given every four to six months or as decided by the investigator. During the study, visual acuity will be measured before and after treatment using standard tests. Imaging of the retina, including OCT and Fundus Autofluorescence (FAF), will be done at screening and after each treatment cycle. The study will monitor changes in vision and retinal images over approximately 31 months to assess treatment effects and safety.
CONDITIONS
Brief Title
A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis or confirmation of dry age-related macular degeneration by the investigator
- Ability to communicate well with the investigator and understand study requirements
- Provided written informed consent for study participation (including retrospective participants who consent before data use)
You will not qualify if you...
- Signs or history of active or inactive exudative macular neovascularization
- History or presence of intra or subretinal fluid from any cause
- Use of photosensitizing agents activated by the Valeda Light Delivery System within 30 days before treatment without physician consultation
- Known photosensitivity to yellow, red, or near-infrared light or history of light-activated central nervous system disorders such as epilepsy or migraine
- Any condition that may interfere with participation or is not in the participant's best interest, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 4 weeks
Participants receive nine non-invasive photobiomodulation treatments over three to four weeks using the Valeda Light Delivery System.
9 treatment visits
Duration - Up to 31 months
Participants may receive up to five additional rounds of photobiomodulation treatments every four to six months as determined by the investigator.
Additional treatment visits every 4 to 6 months
Duration - Up to 31 months
Visual acuity, OCT imaging, and Fundus Autofluorescence imaging are collected prior to and following each treatment round to assess safety and effectiveness.
Imaging and visual assessments after each treatment round
Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
S
Stephanie Tedford, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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