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

February 16, 2021 updated by: LumiThera, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3E8
        • 1929 Bayview Avenue, Unit 117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of one year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of one year.
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.
Through study completion, an average of one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LumiThera, Inc.

Collaborators

National Eye Institute (NEI)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP001
  • 1R43EY025508-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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