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

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
LT-300 Active (PBM)
LT-300 Inactive (Sham)
Sponsored by
LumiThera, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring Dry AMD, Vision Loss, AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 1929 Bayview Avenue, Unit 117

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Photobiomodulation Treatment

Sham Treatment

Arm Description

Treatment with Photobiomodulation to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months.

Sham treatment to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months.

Outcomes

Primary Outcome Measures

Visual Acuity changes from baseline to month 12.
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

Secondary Outcome Measures

Contrast Sensitivity
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)
OCT will be measured using the Spectralis SD-OCT to compare changes in dry AMD pathology.

Full Information

First Posted
March 23, 2016
Last Updated
February 16, 2021
Sponsor
LumiThera, Inc.
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT02725762
Brief Title
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration
Acronym
LIGHTSITE1
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 Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LumiThera, Inc.
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Dry AMD, Vision Loss, AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation Treatment
Arm Type
Experimental
Arm Description
Treatment with Photobiomodulation to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months.
Arm Title
Sham Treatment
Arm Type
Sham Comparator
Arm Description
Sham treatment to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months.
Intervention Type
Device
Intervention Name(s)
LT-300 Active (PBM)
Intervention Type
Device
Intervention Name(s)
LT-300 Inactive (Sham)
Primary Outcome Measure Information:
Title
Visual Acuity changes from baseline to month 12.
Description
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
Time Frame
Through study completion, an average of one year.
Secondary Outcome Measure Information:
Title
Contrast Sensitivity
Description
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
Time Frame
Through study completion, an average of one year.
Title
Optical Coherence Tomography (OCT)
Description
OCT will be measured using the Spectralis SD-OCT to compare changes in dry AMD pathology.
Time Frame
Through study completion, an average of one year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Markowitz, MD
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert G Devenyi, MD
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
1929 Bayview Avenue, Unit 117
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392581/
Description
LIGHTSITE I Results

Learn more about this trial

Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration

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