Age-related Macular Degeneration (AMD) Clinical Trial
Official title:
Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders (Diabetic Retinopathy, Dry AMD, Hard Drusen Formation) for Alzheimer's Disease Prevention
The study will explore the impact of photobiomodulation (PBM), pulsating at frequencies of red (660nm) and near-infrared (810nm)(NIR), concurrent with a ketogenic dietary protocol (serum ketones @ .5 - 2.0 mmol/L) to mediate vascular features of diabetic retinopathy (DR), diabetic macular edema (DME), age-related macular degeneration (AMD), mid-peripheral drusens, visual acuity and retinal disorders. Red and near-infrared light via light-emitting diode (LED) treatment promotes retinal healing and improves visual acuity by augmenting cellular energy metabolism, enhancing mitochondrial function, increasing cytochrome C oxidase activity, stimulating antioxidant protective pathways and promoting cell survival. LED therapy directly benefits neurons in the retina, the lateral geniculate nucleus and the visual cortex; likewise, a ketogenic dietary protocol shows metabolic and neuro-modulatory benefits within the CNS, most notably as treatment for refractory epilepsy. Photobiomodulation has been approved as a non-significant risk (NSR) modality for the treatment of eye disorders.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 30, 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: Male or Female (age 18-80) Previously diagnosed with MetS and/or T2DM as measured by possessing at least 2 of the following physiological measures: type II diabetes, BMI >30, HgA1c > 5.7, waist/height ratio >.6, fasting glucose > 125 Previously diagnosed with at least one of the following: mid-peripheral drusen formation, diabetic retinopathy (DR), age-related macular degeneration (AMD) or diabetic macular edema Exclusion Criteria: Previously diagnosed with Alzheimer's disease (AD), dementia or Parkinson's disease |
Country | Name | City | State |
---|---|---|---|
United States | Yankee Eye Clinic | Eagan | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Bristlecone Health, Inc. | University of Minnesota - Clinical and Translational Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diabetic Retinopathy (DR) pathology | Improvement in number and severity of hemorrhages and hard and soft exudates as measured by the Daytona Plus (Panoramic Ophthalmoscope P200T) | 36 weeks | |
Primary | Diabetic Macular Edema (DME) pathology | Lower incidence of macular edema as measured by Optos Daytona Plus (Panoramic Ophthalmoscope P200T) and Optovue XR Avanti 3 OCT (Ocular Coherence Tomography) Imaging Systems | 36 weeks | |
Primary | Dry Age-related Macular Degeneration (AMD) pathology | Reduction in size and number of drusen in early and intermediate stages of Dry AMD pathology as measured byOptos Daytona Plus (Panoramic Ophthalmoscope P200T) and Optovue XR Avanti 3 OCT (Ocular Coherence Tomography) Imaging Systems | 36 weeks | |
Primary | Hard Drusen in the Mid-periphery pathology | Reduction in size and/or density of drusen as measured by the Optos Daytona Plus (Panoramic Ophthalmoscope P200T) | 36 weeks | |
Secondary | HgA1c | Assessment of changes in HgA1c (Hemoglobin A1c) over time. Ranges: <5.7% | 36 weeks | |
Secondary | Fasting Insulin | Assessment of changes in fasting insulin over time. Ranges: < 2.6-11.1 mU/L | 36 weeks | |
Secondary | Fasting Glucose | Assessment of changes in fasting glucose over time. Ranges 74-100 mg/dL | 36 weeks | |
Secondary | HOMA-IR | Assessment of changes in HOMA-IR over time. Ranges <1.0 | 36 weeks | |
Secondary | Triglycerides/HDL ratio | Assessment of changes in triglycerides/HDL ratio over time. Ranges <2.0 | 36 weeks |
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