LumiThera Initiates EUROLIGHT Registry Study to Evaluate Long-Term Benefits of PBM Using the Valeda for Dry AMD
LumiThera announced the initiation of the largest PBM trial ever conducted in patients with dry age-related macular degeneration (AMD). A global registry data collection from patients treated with PBM using the Valeda Light Delivery System has been established with Dendrite Clinical Systems LTD, a UK-based company specializing in registry studies. The multicenter clinical registry study will enroll 500 to 1,000 patients treated with PBM over the past 3 years. The study will initially include up to 20 European centers and could be expanded in other countries outside the Europe Union (EU) where Valeda is approved.
EUROLIGHT (European Union Registry Study) will collect safety and clinical efficacy outcomes such as best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) imaging data from multiple centers that have been treating dry AMD subjects in their practice. The registry will collect data retrospectively with centers providing existing data from subjects who underwent PBM treatment every 4-6 months for up to 3 years. Patients will continue to be followed prospectively. The data will be used to support reimbursement in multiple countries and provide important clinical information on real-world use of Valeda. The study has targeted select European centers with extensive expertise in the use of Valeda.
“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, LumiThera, said in a company news 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 current registry collection will examine patients from early through late stage AMD disease and provide evidence of safety, clinical efficacy, and biomarkers from imaging data. An estimated 16,000 patients in Europe and Latin America have been treated to date and represents a valuable dataset to garner further information about PBM treatment and AMD disease progression.
“We are very excited that the Duke Reading Center has been chosen as the independent image reading center to review data from real-world use of Valeda,” stated Glenn Jaffe, MD, Robert Machemer Professor of Ophthalmology, Duke University and Director of Duke Reading Center. “PBM treatment showed a statistically significant slowing of disease progression in patients with early to intermediate dry AMD for up to 2 years in the LIGHTSITE III study. The global registry study will provide us with a unique dataset to evaluate disease biomarkers and disease progression, including drusen deposition and new geographic atrophy (GA) formation and lesion growth rates.”
“We have seen recent publications from the real-world setting that mirror our RCT trial results and we have several years of experience with Valeda treatments in the EU and LATAM,” said Clark Tedford, PhD, President and CEO, LumiThera. “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 GA lesion rates with detailed anatomical OCT analysis in several subsets of patients.”