Dendrite Clinical Systems and LumiThera have initiated the largest photobiomodulation (PBM) study ever conducted. The multi-center clinical registry, EUROLIGHT (European Union Registry Study) will enroll 500 to 1000 patients treated with with PBM using the LumiThera Valeda Light Delivery System in the EU over the past three years. The study will initially include up to 20 European centres and could be expanded in other countries outside the Europe Union (EU) where Valeda is approved.

Utilising Dendrite’s intuitive and robust ‘Intellect-Web Registry’ software, EUROLIGHT will collect safety and clinical efficacy outcomes such as best corrected visual acuity (BCVA) and Optical Coherence Tomography (OCT) imaging data from multiple centres that have been treating dry Age-Related Macular Degeneration (AMD) subjects in their practice. This large registry will collect data retrospectively with centres providing existing data from subjects who underwent PBM treatment every 4-6 months for up to three 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.

“We are delighted that the EUROLIGHT Registry has been launched across multiple centres throughout Europe. EUROLIGHT is a highly-complex registry in terms of its capacity to track multiple treatments, whilst simultaneously collecting and recording both procedural and outcomes data at differing time sets from multiple centres,” said Dr Peter Walton, Managing Director of Dendrite Clinical Systems. “This bespoke registry design has been developed over several months and I would like to thank everyone involved in the process, and we look forward to seeing the outcomes in due course.”

Dendrite’s Intellect-Web Registry software enables users (clinicians, hospitals, societies and associations, healthcare companies etc) to collect, analyse, track and report procedural, treatment and outcomes data for clinical audit and benchmarking, research, clinical trials and Real World Evidence studies. The flexible system can be tailored for any clinical scenario and is designed to support multiple specialties and at multiple locations. Data can be entered safely and securely on smart-phones, tablets or computers anywhere in the world via the internet, with the data automatically updated to the registry. The system’s unique ‘Visual Dashboard’ facilitates real-time data analysis reflecting the required analysis/reporting needs, and the recently launched innovative e-PROMS module allows contacts to receive and answer questionnaires remotely.

“We are thrilled to be part of the Eurolight study,” said Dr Oygunn Uthiem, MD, PhD, Norwegian Dry Eye Clinic / Øyehelseklinikken, Department of Medical Biochemistry/Department of Ophthalmology, Oslo University Hospital, Oslo, Norway. “We have treated over 350 patients in the last four years and have seen the real world benefits of the Valeda treatments for our patients. We have started to upload data into the registry database and have obtained over 70 informed consents from patients that want to be part of the study. Our patients have strictly followed the clinical trial protocols and been tested every 4-6 months, some for up to four years.”

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 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,” stated Clark Tedford, Ph.D., 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 GA lesion growth rates.”

About AMD

AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, read, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).

About Dendrite

Dendrite Clinical Systems is a UK-headquartered international company with over a 30-year track record as a specialist provider of secure clinical registries, analysis software and consultancy services for the international healthcare sector, specifically for clinical research, multi-centre real-world studies, observational registries, international, national and hospital clinical databases.

Dendrite has been recognised as a leading provider of clinical registries across various specialties with a unique track record of implementing over 200 major clinical registry systems globally including systems for major research projects for medical device companies, CROs and pharmaceutical companies.

About LumiThera

LumiThera, Inc. is a medical device company focused on diagnosing, treating, and monitoring ocular disease and damage including dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 65.

LumiThera’s flagship product, the Valeda® Light Delivery System, uses multiwavelength photobiomodulation to treat dry AMD patients. Valeda is CE Marked in the EU and is available in Europe and in countries in Latin America. Valeda is not yet approved by the Food & Drug Administration (FDA).

AdaptDx Pro® dark adaptation functional testing technology enables eye care professionals to detect and monitor AMD three years before clinical presentation. AdaptDx Pro is listed on the FDA’s Establishment Registration & Device Listing.

Diopsys ERG and VEP systems help eye care professionals analyze the entire pathway for visual and neuro-visual disorders. VEP is FDA-cleared. ERG and VEP are available in select countries outside of the USA.

LumiThera’s AMD Excellence Program® provides customer implementation, training, best practices, and ongoing support across all brands.

For more information about the EUROLIGHT (European Union Registry Study) Registry, please visit: https://demo.e-dendrite.com/lumithera/