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

• Sponsor: LumiThera, Inc.
• Collaborator: National Eye Institute (NEI)
• Information provided by (Responsible Party): LumiThera, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Age Related Macular Degeneration	Device: LT-300 Active (PBM); Device: LT-300 Inactive (Sham)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Ontario

1929 Bayview Avenue, Unit 117

Toronto, Ontario, Canada, M4G 3E8

Sponsors and Collaborators

LumiThera, Inc.

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

More Information

• Responsible Party: LumiThera, Inc.
• ClinicalTrials.gov Identifier: NCT02725762 History of Changes
• Other Study ID Numbers: CSP001; 1R43EY025508-01 ( U.S. NIH Grant/Contract )
• First Posted: April 1, 2016
• Last Update Posted: August 9, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by LumiThera, Inc.:

Dry AMD; Vision Loss; AMD

Additional relevant MeSH terms:

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases