EUROLIGHT registry study to evaluate photobiomodulation in dry AMD
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LumiThera announced the EUROLIGHT registry study will evaluate the safety, efficacy and biomarkers of photobiomodulation treatment for dry age-related macular degeneration.
“The LIGHTSITE series of trials demonstrated improvements of visual benefits with PBM treatments in a prospective randomized clinical trial (RCT) design,” René Rückert, MD, MBA, chief medical officer of LumiThera, said in a press release. “The RCT results demonstrated clinical benefits in early to intermediate patients out to 2 years with anatomical evidence of slowing of AMD disease progression.”
The multicenter clinical registry study will involve 500 to 1,000 patients treated over the past 3 years with photobiomodulation (PBM) using the Valeda light delivery system. Initially the study will focus on 20 European centers, but it could be expanded to other countries where Valeda is approved.
Retrospective data will be collected while the patients are followed prospectively. The goal is to collect data on the treatment to support reimbursement as well as information on the real-world use of Valeda.
“The ability to collect additional safety and efficacy data from our global experiences will help us continue to study the safety and effectiveness of PBM in early to late-stage disease treatment of dry AMD and its effect on the progression of disease and growth of [geographic atrophy] lesion rates with detailed anatomical OCT analysis in several subsets of patients,” Clark Tedford, PhD, president and CEO of LumiThera, said in the release.
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