- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00940407
Toronto and Oak Ridge Photobiomodulation Study for Dry Age Related Macular Degeneration (TORPA)
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.
Study Overview
Status
Intervention / Treatment
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.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5R 1C4
- Dr Graham Merry
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Tennessee
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Oak Ridge, Tennessee, United States, 37830
- Dr Robert Dotson
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in ETDRS Visual Acuity
Time Frame: prior to intervention and 3 monthly intervals to 1 year
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prior to intervention and 3 monthly intervals to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in contrast sensitivity
Time Frame: prior to intervention and 3 monthly to 1 year
|
prior to intervention and 3 monthly to 1 year
|
changes in retinal function parameters from Nidek MP1 assessment
Time Frame: prior to intervention and 3 monthly to 1 year
|
prior to intervention and 3 monthly to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Graham F Merry, MBBS; LMCC, Dr. Graham Merry
- Principal Investigator: Robert Dotson, M.D., Dr. Robert Dotson
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOPRPA 08001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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