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Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)
Not Recruiting
Trial ID: NCT04065490
Purpose
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.
Official Title
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)
Stanford Investigator(s)
Diana Do, MD
Professor of Ophthalmology
Eligibility
Inclusion Criteria:
1. Male or female at least 50 years of age at Screening visit
2. 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.
3. 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
4. Able to communicate well with the Investigator and able to understand and comply with
the requirements of the study
5. Informed of the nature of this study and has provided written, informed consent in
accordance with institutional, local and national regulatory guidelines
Exclusion Criteria:
1. Current or history of neovascular maculopathy that includes any of the following (to
be confirmed by the reading center):
1. Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating
from the choroidal vasculature that extends through a defect in Bruch's membrane
2. Serous and/or hemorrhagic detachment of the neurosensory retina or retinal
pigment epithelial (RPE)
3. Retinal hard exudates (a secondary phenomenon resulting from chronic
intravascular leakage)
4. Subretinal and sub-RPE fibrovascular proliferation
5. Disciform scar (subretinal fibrosis)
2. Presence of center involving GA within the central ETDRS 1 mm diameter at Screening,
to be confirmed by the reading center
3. 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.
4. 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.
5. Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3
months prior to Screening
6. Ocular disorder or disease that partially or completely obstructs the pupil (e.g.
posterior synechia in uveitis)
7. 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)
8. 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)
9. Presence or history of disease or condition affecting functional vision without
obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus)
10. 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
11. 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
12. Is non-ambulatory
13. 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)
14. Use of any photosensitizing agent (e.g. topicals, injectables, oral) within 30 days of
treatment without consulting subject's physician
15. History of drug, alcohol or substance abuse within 3 months prior to Screening
16. Has received an investigational drug or treatment with an investigational device
within 3 months prior to Screening
17. 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.
18. Has received Low Vision Rehab/Therapy within 30 days prior to Screening or intends to
receive during the study
19. 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.
20. In the opinion of the Investigator, is unlikely to comply with the study protocol
Intervention(s):
device: Valeda PBM treatment
device: Valeda Sham treatment
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305