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Completed
NCT02725762
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration
Conditions: Age Related Macular Degeneration
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: LumiThera, Inc.
Location: 1929 Bayview Avenue, Unit 117 Toronto Ontario
Summary
The purpose of this research study is to determine if photobiomodulation is an effective treatment of Dry Age-Related Macular Degeneration (AMD) and vision loss associated with the disease.
Eligibility Criteria
Inclusion Criteria:
* Patients of both gender
* 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 surgery 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. The other eye may be treated but not included in the study; for example advanced geographic atrophy.
* Patients with severe clinically significant disease or unstable medical disorders 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 effects of PBM on the developing human 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.
Source: ClinicalTrials.gov (NCT02725762). StuddyBuddy aggregates publicly available trial information.