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

Primary Purpose

Age Related Macular Degeneration

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Photobiomodulation

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration

Eligibility Criteria

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

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

Sites / Locations

Perich Eye Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photobiomodulation

Arm Description

Valeda™ Light Delivery System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04522999

First Posted

August 11, 2020

Last Updated

August 31, 2021

Sponsor

LumiThera, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04522999

Brief Title

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

Acronym

ELECTROLIGHT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

August 20, 2020 (Actual)

Primary Completion Date

August 13, 2021 (Actual)

Study Completion Date

August 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LumiThera, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age Related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Photobiomodulation

Arm Type

Experimental

Arm Description

Valeda™ Light Delivery System

Intervention Type

Device

Intervention Name(s)

Photobiomodulation

Intervention Description

The Valeda™ Light Delivery System

Primary Outcome Measure Information:

Title

ERG function

Description

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

ETDRS Visual Acuity

Description

Measurement of Visual function.

Time Frame

3 months

Title

Mars Contrast Sensitivity

Description

Measurement of Visual function.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Perich Eye Center

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34655

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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