Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III) (NCT04065490) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)
United States96 participantsStarted 2019-09-01
Plain-language summary
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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.