Study to Assess Safety and Effectiveness of reSEES Light Therapy for Patients Aged 50 and Older with Intermediate Age-Related Macular Degeneration

What this Trial Is About

Researchers are investigating a new light therapy called reSEES for people with intermediate age-related macular degeneration AMD. This study primarily aims to confirm the safety of this innovative approach, which combines two laser-light treatments with established safety recordsthe photothermal and photobiological techniques. The study also aims to observe how this combined therapy might affect the progression of intermediate AMD over one year, comparing treated eyes with the untreated fellow eyes as controls. Participants will receive the reSEES treatment on one eye, usually the left or the worse eye, while the other eye serves as a control. The treatment involves nine sessions over three weeks, combining selective micropulse laser SMPL and photobiomodulation PBM therapies. Treatment visits occur twice weekly, with paired sessions on the first visit of each week and PBM alone on the second. After treatment, patients will have follow-up visits at 18, 24, and 52 weeks to monitor effects and safety. During the 52-week study period, participants will attend a total of 10 visits for assessments including eye exams, visual acuity tests, and imaging scans such as fundus autofluorescence and near-infrared scanning laser ophthalmoscopy. Researchers will track safety by checking for laser-light spot absence and adverse events. They will also evaluate changes in retinal structure, function, vision, mood, and general well-being. Medical history and medication use will be recorded throughout to support comprehensive monitoring.

A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD