Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITEIIIB)

Dry Age-related Macular Degeneration Clinical Trial

Official title: An Open-Label, Prospective, Multi-Center Extension Study to Assess the Long-Term Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE IIIB)

Status Recruiting

Clinical Trial Summary

This study is an open-label, prospective, multi-center extension study on the continued use of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) that participated in the CSP005 LIGHTSITE III study.

Clinical Trial Description

This study is an open-label, prospective, multi-center study on the use of PBM as a treatment for visual impairment in subjects with dry AMD. Subjects diagnosed with dry AMD who meet all inclusion criteria and have none of the exclusion criteria will be eligible to participate in this clinical study. All subjects will be treated with the Valeda Light Delivery System and will receive PBM treatment for a total of 9 treatments over a three to five-week period (3 times per week for 3 weeks is preferable). There will be a re-treatment period starting at the 4-month time point to include 9 additional treatment visits, to be repeated again at 8 months and 12 months. LumiThera will use settings for the 3 wavelengths that were used in the CSP005 study. The subject population for this study will consist of all subjects that completed the CSP005 study, meet the inclusion/exclusion criteria for the CSP010 study, are interested in study participation and have signed the Informed Consent Form. ;

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Macular Degeneration

• NCT number: NCT06229665
• Study type: Interventional
• Source: LumiThera, Inc.
• Contact: Cindy Croissant, MBA
• Phone: 18583971021
• Email: ccroissant@lumithera.com
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 25, 2023
• Completion date: June 1, 2025