A pilot clinical study to evaluate the use of photobiomodulation in patients with dry age-related macular degeneration

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 DESCRIPTION (provided by applicant): As the population continues to age, degenerative ocular diseases become increasingly common and create tremendous burden on the health care system. Vision impairment in the elderly with AMD takes away an average of 5 quality years of life. Age-related macular degeneration (AMD) represents a large market with ~2 million patients and another ~8 million people at risk in the U.S. alone. Approximately, 90% of the AMD patients have the "dry" form of the disease. There are no approved treatments for dry AMD and, thus it represents a potential high impact, targeted area in medicine. A investigator study lead by Drs. Merry and Dotson from The Toronto and Oak Ridge Study of Photobiomodulation (TORPA) looked at the effect of low level light therapy (LLLT) in the treatment of dry AMD. The TORPA data for dry AMD shows clinically and statistically significant improvement in visual acuity and contrast sensitivity, immediately after treatment for 6 weeks, demonstrating the potential use of LLLT in dry-AMD. The TORPA study combined multiple pre-selected wavelengths to stimulate mitochondrial CCO function and suppress VEGF expression. The study conclusions were that LED treatment was a non- invasive, easily administered and safe treatment with no serious adverse events noted. More importantly, the study provides the only 1 year follow-up data of LED effectiveness in dry AMD. These findings are the first to demonstrate a statistically significant clinical benefit (F(4,68) = 18.86, p < 0.0001) at up to 1 yr in dry AMD patients with LLLT. LumiThera was formed from founders with extensive clinical and developmental expertise in photobiomodulation to lead in the commercialization efforts. Multiple wavelength LED clinical and prototype commercial instruments are being designed and built for an ophthalmologist office-based setting. The current SBIR proposal is to conduct a pilot prospective, double-masked clinical trial with LumiThera's ophthalmological designed LED instrument, LT-300. Specific Aim 1 will establish the magnitude of clinical and OCT imaging benefit of multiple LED wavelengths on 20 dry AMD patients, divided into two groups. Approximately 10 subjects will be treated in group 1, and approximately 10 subjects will be given a sham treatment in group 2 over a three-week period (3 times per week for 3). LED Treatments will be administered by Dr. Merry, masked to the outcome measures. Drs Devenyi and Markowitz (University of Toronto) will act as co-investigators and provide patient recruitment, review all clinical data and AEs and imaging scans. All subjects will undergo Retinal Specialist assessment, Ocular Coherence Tomography (OCT) and Intra-venous Fluoroscein Angiography (IVFA) prior to enrollment to ensure non-neovascular AMD. All subjects are assessed with ETDRS logMAR Visual Acuity at 4 meters, contrast sensitivity at 1.5 and 3 cycles per degree. Clinical and OCT Measurements will take place prior to treatment, immediately following the treatment protocol (3 weeks), 3, 6, 12 months after. The findings will provide the basic safety and scientific foundation for a pivotal trial with a novel non- invasive, non-pharmaceutical therapy for dry-AMD.