Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration

Study Overview
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Brief Summary
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The purpose of this study is to evaluate clinical outcomes of Photobiomodulation treatment on patients with dry Age Related Macular Degeneration (AMD). Photobiomodulation is the use of non thermal, non laser light of specific wavelengths and energy directly on the eye to improve retinal function and delay AMD progression. This is a prospective 2 center phase 2 clinical pilot study with no placebo group.

Detailed Description
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Dry AMD is a progressive sight threatening disease affecting central acute vision. Dry AMD may progress to the wet form where leaking and bleeding in the retina can cause sudden severe visual loss. There are no proven active treatments for Dry AMD. Dry AMD accounts for over 80% of AMD cases. There are estimated to be 30 million people afflicted with AMD by the year 2020 in North America. Photobiomodulation in this study is utilised by using two devices that are already approved for other indications by the FDA and Health Canada. Photobiomodulation is a novel clinical application for treating dry AMD. As this is a pilot study there is no placebo or control group.

Official Title
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A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.

Conditions
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Nonexudative Age-related Macular Degeneration

Intervention / Treatment
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* Device: Photobiomodulation (Gentlewaves, Warp 10)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of both genders aged 50 years inclusive and over patients must have DRY macular degeneration in the study eye best corrected visual acuity between 20/40 and 20/200 patients must be competent to sign and have signed a consent form before study entry Exclusion Criteria: visually significant cataracts presence of a visually significant posterior capsule if prior cataract has been performed any visually significant disease process in any ocular structure that would affect vision unrelated to macular degeneration a patient can be enrolled if only one of their eyes meets the criteria patients with severe clinically significant medical disease or unstable medical conditions including cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, CNS or life threatening disease or current malignancy at the discretion of the investigators patients who are non-ambulatory or bed ridden female patients who are pregnant or of childbearing potential as the effects of PBM on the developing fetus are unknown patients with a history of epilepsy patients with a history of alcohol, drug or substance abuse in the past 6 months patients deemed uncooperative or non compliant with the requirements of the protocol patients who have received any investigational drug or treatment within 30 days prior to study entry patients who are not competent to understand and sign consent form

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Photobiomodulation (Gentlewaves, Warp 10)|Two separate light emitting devices that are already approved for other indications are used. Treatment will consist of 18 treatments lasting approximately two minutes per treatment.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ETDRS Visual Acuity |  | prior to intervention and 3 monthly intervals to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in contrast sensitivity |  | prior to intervention and 3 monthly to 1 year | 
| changes in retinal function parameters from Nidek MP1 assessment |  | prior to intervention and 3 monthly to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry AMD, light treatment, ARMD, photobiomodulation, macular, eye disease, ageing eye disease