Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration (NCT00940407) | Clinical Trial Compass
CompletedPhase 2
Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration
United States, Canada18 participantsStarted 2009-01
Plain-language summary
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.
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:
* 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
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.
What they're measuring
1
Change in ETDRS Visual Acuity
Timeframe: prior to intervention and 3 monthly intervals to 1 year