Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration

NCT ID: NCT02725762

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-07-31

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.

Conditions

Age Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

LT-300 Active (PBM)

Intervention Type: DEVICE

Sham Treatment

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

Group Type: SHAM_COMPARATOR

LT-300 Inactive (Sham)

Intervention Type: DEVICE

Interventions

LT-300 Active (PBM)

Intervention Type: DEVICE

LT-300 Inactive (Sham)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

LumiThera, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Markowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Robert G Devenyi, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

1929 Bayview Avenue, Unit 117

Toronto, Ontario, Canada

Countries

Canada

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392581/

LIGHTSITE I Results

Other Identifiers

1R43EY025508-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CSP001

Identifier Type: -

Identifier Source: org_study_id