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Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02725762
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
LumiThera, Inc.

Tracking Information
First Submitted Date  ICMJE March 23, 2016
First Posted Date  ICMJE April 1, 2016
Last Update Posted Date September 10, 2019
Study Start Date  ICMJE March 2016
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02725762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration
Official Title  ICMJE 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
Brief 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age Related Macular Degeneration
Intervention  ICMJE
  • Device: LT-300 Active (PBM)
  • Device: LT-300 Inactive (Sham)
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Device: LT-300 Inactive (Sham)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 28, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02725762
Other Study ID Numbers  ICMJE CSP001
1R43EY025508-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party LumiThera, Inc.
Study Sponsor  ICMJE LumiThera, Inc.
Collaborators  ICMJE National Eye Institute (NEI)
Investigators  ICMJE
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
PRS Account LumiThera, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP