Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE1)
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|ClinicalTrials.gov Identifier: NCT02725762|
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Device: LT-300 Active (PBM) Device: LT-300 Inactive (Sham)||Not Applicable|
The LumiThera LT 300® Light Delivery System is a stationary desktop instrument used to emit energy in the visible and near infrared spectrum. The LT-300® is designed for the ophthalmologist to use in the treatment of the eye with photobiomodulation (PBM), a process by which cellular mechanisms are induced by light. PBM is being utilized in many indications, such as wound healing, soft tissue injuries, joint pain, myofascial pain, nerve injuries, muscle fatigue for temporary improvement in blood flow and reduction in inflammation. The mechanism of PBM at the cellular level has been ascribed to the activation of mitochondrial respiratory chain components resulting in stabilization of metabolic function and initiation of a signaling cascade, which promotes cellular proliferation and cytoprotection. The LT-300® will provide a preset treatment of PBM to the subject's eye and retinal tissue through the open and closed eyelid.
Approximately 30 subjects meeting the eligibility requirements of the study will be randomly assigned in a 1:1 ratio to receive standard of care treatment for Dry AMD plus PBM treatment with the LT-300 system, or standard of care treatment for Dry AMD plus Sham treatment with the LT-300 system. Subjects randomized to each group will receive two 3-week treatment sessions (9 treatments per session) and follow-up visits extending to one year. The primary objective of the study is to evaluate the safety and efficacy of PBM with respect to visual and anatomical outcomes of subjects with Dry AMD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Single-Center Study to Assess the Safety and Efficacy of Photobiomodulation in Subjects With Dry Age-Related Macular Degeneration|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
Experimental: Photobiomodulation Treatment
Treatment with Photobiomodulation to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months.
Device: LT-300 Active (PBM)
Sham Comparator: Sham Treatment
Sham treatment to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months.
Device: LT-300 Inactive (Sham)
- Visual Acuity changes from baseline to month 12. [ Time Frame: Through study completion, an average of one year. ]Visual acuity will be measured using ETDRS VA letter scoring to test the difference between the sham and treatment subjects in mean change from Baseline to Month 12
- Contrast Sensitivity [ Time Frame: Through study completion, an average of one year. ]Contrast Sensitivity will be measured using the FACT Contrast Sensitivity Chart to test the difference between the sham and treatment subjects in mean change from Baseline to Month 12
- Optical Coherence Tomography (OCT) [ Time Frame: Through study completion, an average of one year. ]OCT will be measured using the Spectralis SD-OCT to compare changes in dry AMD pathology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725762
|1929 Bayview Avenue, Unit 117|
|Toronto, Ontario, Canada, M4G 3E8|
|Principal Investigator:||Samuel Markowitz, MD||Private Practice|
|Principal Investigator:||Robert G Devenyi, MD||Ophthalmologist in Chief and Director of Retinal Services, The Donald K. Johnson Eye Center, University Health Network; Professor of Ophthalmology, The University of Toronto; Vitreoretinal Surgery Lead, The Kensington Eye Institute|