Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration

NCT02725762 | Completed

• 2 other identifiers: CSP0011R43EY025508-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

Dry AMD; Vision Loss; AMD

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of one year.

Secondary Outcomes (2)

• Contrast Sensitivity

  Through study completion, an average of one year.

• Optical Coherence Tomography (OCT)

  Through study completion, an average of one year.

Study Arms (2)

Photobiomodulation Treatment

EXPERIMENTAL

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 Treatment

SHAM COMPARATOR

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)

Interventions

LT-300 Active (PBM) DEVICE

Photobiomodulation Treatment

LT-300 Inactive (Sham) DEVICE

Sham Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LumiThera, Inc.: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

1929 Bayview Avenue, Unit 117

Toronto, Ontario, M4G 3E8, Canada

Location

Related Links

• LIGHTSITE I Results

MeSH Terms

Conditions

Macular Degeneration; Vision Disorders

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 1, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

CA (1)