Status:
COMPLETED
Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration
Lead Sponsor:
Merry, Graham, M.D.
Conditions:
Nonexudative Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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, n...
Detailed Description
Dry AMD is a progressive sight threatening disease affecting central acute vision. Dry AMD may progress to the wet form where leaking and bleeding in the retina can cause sudden severe visual loss. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00940407
Start Date
January 1 2009
End Date
August 1 2011
Last Update
November 18 2011
Active Locations (2)
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1
Dr Robert Dotson
Oak Ridge, Tennessee, United States, 37830
2
Dr Graham Merry
Toronto, Ontario, Canada, M5R 1C4