Status and phase
Conditions
Treatments
About
This study is an open-label, prospective, multi-center extension study on the continued use of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) that participated in the CSP005 LIGHTSITE III study.
Full description
This study is an open-label, prospective, multi-center study on the use of PBM as a treatment for visual impairment in subjects with dry AMD. Subjects diagnosed with dry AMD who meet all inclusion criteria and have none of the exclusion criteria will be eligible to participate in this clinical study. All subjects will be treated with the Valeda Light Delivery System and will receive PBM treatment for a total of 9 treatments over a three to five-week period (3 times per week for 3 weeks is preferable). There will be a re-treatment period starting at the 4-month time point to include 9 additional treatment visits, to be repeated again at 8 months and 12 months. LumiThera will use settings for the 3 wavelengths that were used in the CSP005 study. The subject population for this study will consist of all subjects that completed the CSP005 study, meet the inclusion/exclusion criteria for the CSP010 study, are interested in study participation and have signed the Informed Consent Form.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Entry Criteria: Inclusion Criteria (each eye qualifies for the study independently):
Exclusion Criteria (each eye qualifies for the study independently):
Current or history of neovascular maculopathy that includes any of the following (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 12 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 12 months.
Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three months prior to Baseline
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 3 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) activated by the Valeda Light Delivery System wavelengths within 30 days of treatment without consulting subject's physician
History of drug, alcohol or substance abuse within 3 months prior to Baseline
Participation in any other clinical study at time of Baseline, or has received an investigational drug or treatment with an investigational device within 3 months prior to Baseline
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 Baseline. 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 Baseline 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
Primary purpose
Allocation
Interventional model
Masking
75 participants in 1 patient group
Loading...
Central trial contact
Cindy Croissant, MBA; Stephanie Tedford, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal