Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration (ELECTROLIGHT)

An Objective Study to Evaluate the Ability of Photobiomodulation to Improve Electroretinogram Outcomes in Subjects With Dry Age-Related Macular Degeneration

To evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD).

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Device: Photobiomodulation

Detailed Description

This study is an open label, prospective pilot study to evaluate retinal function after PBM treatment in eyes with dry AMD using ERG. The target enrollment is 15 subjects in up to two sites in the US. All subjects will receive PBM Treatment.

Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over 3 weeks.

The primary analysis will examine multi-focal ERG function changes from baseline to Month 1. Secondary analyses will examine multi-focal ERG function change from baseline to Month 3 and 6. Other endpoints will include other functions of ERG, ETDRS Visual Acuity, Contrast Sensitivity, Perimetry, Color Vision test and the Amsler grid test.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • New Port Richey, Florida, United States, 34655
      • Perich Eye Center

Participation Criteria

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:

• Male or female at least 50 years of age at Screening visit
• ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32)
• Diagnosis of dry AMD
• Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
• Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines

Exclusion Criteria:

• Current or history of neovascular maculopathy
• Presence of center involving GA within the central ETDRS 1 mm diameter at Screening
• Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s)
• Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s)
• Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
• Visually significant disease in any ocular structure apart from dry AMD
• Serious medical illness that will prevent the subject from performing study activities
• Presence of or history of malignancy within the past 5 years
• Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if they have a history of light activated CNS disorders (e.g. epilepsy, migraine)
• History of neurologic condition known to affect visual function
• History of drug, alcohol or substance abuse within 3 months prior to Screening
• Participation in any other clinical study at time of screening, or has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
• In the opinion of the Investigator, is unlikely to comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation; Valeda™ Light Delivery System	Device: Photobiomodulation; The Valeda™ Light Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ERG function	ERG assessments (Multifocal ERG (mfERG), Photopic Negative Response (PhNR), Multi-luminance Flicker ERG (ML-FERG) and Fixed-luminance Flicker ERG (FL-FERG)) will provide an output of retinal function.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ETDRS Visual Acuity	Measurement of Visual function.	3 months
Mars Contrast Sensitivity	Measurement of Visual function.	3 months

Collaborators and Investigators

• Sponsor: LumiThera, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: CSP007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes