Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration
Completed · Phase 2
Conditions studied: Nonexudative Age-related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT00940407
- Run by
- Merry, Graham, M.D.
- People needed
- 18
- Starts
- 2009-01-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2011-11-18
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dr Robert Dotson — Oak Ridge, Tennessee, United States
- Dr Graham Merry — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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