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 range50 Years
SexALL
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
What they're measuring
1
Change in ETDRS Visual Acuity
Timeframe: prior to intervention and 3 monthly intervals to 1 year