Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)

Study Overview
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Brief Summary
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This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.

Detailed Description
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This study is a double-masked, sham-controlled, parallel design prospective, multi-site study on the use of photobiomodulation (PBM) as a treatment for visual impairment in subjects with dry AMD. Subjects will receive repeated sham or PBM treatments at several time-points throughout the 2-year study.

Official Title
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A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE III)

Conditions
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Dry Age-related Macular Degeneration

Intervention / Treatment
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* Device: Valeda PBM treatment
* Device: Valeda Sham treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 50 years of age at Screening visit ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32). *If the subject meets this criterion at the Screening Visit, but the Baseline BCVA letter score is between 48 and 77, the subject may be entered in the study. Diagnosis of dry AMD as defined by the presence of the following: Drusen that are intermediate in size or larger (63 μm or larger in diameter) with at least a few (3) being regular drusen and not pseudodrusen and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or FAF, to be confirmed by the reading center Able to communicate well with the Investigator and able to understand and comply with the requirements of the study Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines Exclusion Criteria: Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center): Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE) Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage) Subretinal and sub-RPE fibrovascular proliferation Disciform scar (subretinal fibrosis) Presence of center involving GA within the central ETDRS 1 mm diameter at Screening, to be confirmed by the reading center Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 24 months. Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require surgery in the study eye in the next 24 months. Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening Ocular disorder or disease that partially or completely obstructs the pupil (e.g. posterior synechia in uveitis) Visually significant disease in any ocular structure apart from dry AMD (e.g. diabetic macular edema, glaucoma (using >2 eye drop medications, uncontrolled IOP and/or central/paracentral visual field loss), glaucoma surgery, active uveitis, active vitreous disease, intraocular tumor, retinal vascular diseases) Ocular disorder or disease other than dry AMD that could cause drusen (glomerulonephritis Type 2, Autosomal dominant drusen), GA (North Carolina dystrophy) or mitochondrial diseases (parafoveal petaloid GA, Stargardt disease) Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus) Serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study Presence of or history of malignancy within the past 5 years other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ Is non-ambulatory Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if they have a history of light activated CNS disorders (e.g. epilepsy, migraine) Use of any photosensitizing agent (e.g. topicals, injectables, oral) within 30 days of treatment without consulting subject's physician History of drug, alcohol or substance abuse within 3 months prior to Screening Has received an investigational drug or treatment with an investigational device within 3 months prior to Screening If on any anti-oxidant or vitamin Age-Related Eye Disease Study (AREDS) supplement for dry AMD, has not been stabilized for a minimum of 1 month prior to Screening. Subjects are considered to be stable if they are taking the AREDS supplements consistently as prescribed by their treating doctor. Has received Low Vision Rehab/Therapy within 30 days prior to Screening or intends to receive during the study Has an open sore(s) that may come in contact with the Valeda System, has periorbital skin erythema or is prone to such conditions with exposure to light. In the opinion of the Investigator, is unlikely to comply with the study protocol

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Valeda Light Delivery System
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBM Treatment<br>The Valeda™ Light Delivery System | Device: Valeda PBM treatment<br>* The Valeda Light Delivery System<br>|
| Sham Comparator: Sham Treatment<br>The Valeda™ Light Delivery System non-effective treatment | Device: Valeda Sham treatment<br>* The sham mode of the Valeda Light Delivery System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity | Mean change from baseline in BCVA. | 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Sensitivity | Mean change from baseline (pre-treatment) in contrast sensitivity at 40 cm. | 21 months | 
| Central Drusen Volume | Mean change from baseline (pre-treatment) in central Drusen volume. | 21 Months | 
| Central Drusen Thickness | Mean change from baseline (pre-treatment) in central Drusen thickness. | 21 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry age-related macular degeneration, Photobiomodulation, Visual Acuity, Contrast Sensitivity, Drusen, Optical coherence tomography