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ID06351605

Registry Study Evaluating the Safety and Effectiveness of Valeda Photobiomodulation Treatment in Dry Age-Related Macular Degeneration

Led by LumiThera, Inc. · Updated on 2024-04-08

500

Participants Needed

1

Research Sites

13 weeks

Total Duration

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)

Research Team

S

Stephanie Tedford, PhD

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