Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration (ELECTROLIGHT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04522999|
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : September 2, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Device: Photobiomodulation||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Objective Study to Evaluate the Ability of Photobiomodulation to Improve Electroretinogram Outcomes in Subjects With Dry Age-Related Macular Degeneration|
|Actual Study Start Date :||August 20, 2020|
|Actual Primary Completion Date :||August 13, 2021|
|Actual Study Completion Date :||August 13, 2021|
Valeda™ Light Delivery System
The Valeda™ Light Delivery System
- ERG function [ Time Frame: 3 months ]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.
- ETDRS Visual Acuity [ Time Frame: 3 months ]Measurement of Visual function.
- Mars Contrast Sensitivity [ Time Frame: 3 months ]Measurement of Visual function.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522999
|United States, Florida|
|Perich Eye Center|
|New Port Richey, Florida, United States, 34655|
|Responsible Party:||LumiThera, Inc.|
|Other Study ID Numbers:||
|First Posted:||August 21, 2020 Key Record Dates|
|Last Update Posted:||September 2, 2021|
|Last Verified:||August 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|