Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 10/14/2017 |
| Start Date: | January 2009 |
| End Date: | August 2011 |
A Pilot Study to Evaluate Clinical Outcomes of Photobiomodulation in Patients With Age Related Macular Degeneration of the Dry Type.
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.
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.
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.
There are no proven active treatments for Dry AMD. Dry AMD accounts for over 80% of AMD
cases.
There are estimated to be 30 million people afflicted with AMD by the year 2020 in North
America.
Photobiomodulation in this study is utilised by using two devices that are already approved
for other indications by the FDA and Health Canada.
Photobiomodulation is a novel clinical application for treating dry AMD. As this is a pilot
study there is no placebo or control group.
may progress to the wet form where leaking and bleeding in the retina can cause sudden severe
visual loss.
There are no proven active treatments for Dry AMD. Dry AMD accounts for over 80% of AMD
cases.
There are estimated to be 30 million people afflicted with AMD by the year 2020 in North
America.
Photobiomodulation in this study is utilised by using two devices that are already approved
for other indications by the FDA and Health Canada.
Photobiomodulation is a novel clinical application for treating dry AMD. As this is a pilot
study there is no placebo or control group.
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
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