Research Project
9876952
As the population continues to age, degenerative ocular diseases become increasingly common and create a tremendous burden on the health care system. Age-related macular degeneration (AMD) represents a significant problem with 10-11 million patients at risk to progress to severe vision loss in the U.S. alone and the prevalence of AMD is expected to double by 2020. The dry and wet forms of the disease significantly impair visual function and there are no approved treatments for dry AMD, which affects 85-90% of AMD patients. Photobiomodulation (PBM) is a low level light therapy used to induce beneficial cellular processes resulting in significant clinical outcomes, including tissue repair, tissue regeneration and anti-inflammatory effects. At the cellular level, the mechanisms of PBM are ascribed to activation of mitochondrial respiratory chain components resulting in stabilization of metabolic function. Our previous pilot studies demonstrate improvements in clinical (visual acuity (VA) and contrast sensitivity (CS)), anatomical (drusen volume and thickness) and QoL outcomes in PBM-treated patients with Dry AMD. LumiThera Inc. is a medical device company dedicated to establishing novel treatment therapies for ocular indications. Multi-wavelength LED commercial instruments have been designed and built for an ophthalmologist office-based setting. The current SBIR phase II application is to extend the findings from the SBIR phase I pilot study and conduct a prospective, double-masked, multi-center clinical trial with approximately 192 subjects using LumiThera's ophthalmological designed light delivery system, the LT-300. Discussions with the FDA in a presub meeting have established the trial design and discussed potential expedited clearance routes in the US under the Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff. Specific Aims will establish the magnitude of clinical and anatomical outcome benefits of multiple LED wavelengths in dry AMD patients. Subjects with BCVA of 20/32 to 20/80 and no central fovea involvement will be randomized in a 1:2 ratio into sham-treatment or PBM-treatment groups. Subjects will be treated twice during two treatment series within a 9-month long study. A post-marketing annual follow-up reporting period may be included per approval with FDA, separately and could be supported under a phase III NIH program. Each treatment series will consist of PBM or sham treatment 3x/week for 3 weeks for a total of 9 sessions. All subjects will undergo Ocular Coherence Tomography (OCT), Fundus and Autofluorescence (FAF) prior to enrollment to ensure non-neovascular AMD. All subjects will be assessed with ETDRS Visual Acuity, Contrast Sensitivity, Radner Reading Test and Visual Function Questionnaire-25 (QoL). Clinical and imaging measurements will take place prior to treatment, immediately following the treatment and at specified follow-up visits. The grant will support a novel non-invasive, non-pharmaceutical, cost-effective therapy for Dry AMD.
