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

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ClinicalTrials.gov Identifier: NCT04522999
Recruitment Status : Completed
First Posted : August 21, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
LumiThera, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Device: Photobiomodulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Photobiomodulation
Valeda™ Light Delivery System
 Device: Photobiomodulation
The Valeda™ Light Delivery System


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. ETDRS Visual Acuity [ Time Frame: 3 months ]
    Measurement of Visual function.

  2. Mars Contrast Sensitivity [ Time Frame: 3 months ]
    Measurement of Visual function.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Florida
Perich Eye Center
New Port Richey, Florida, United States, 34655
Sponsors and Collaborators
LumiThera, Inc.
More Information
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Responsible Party: LumiThera, Inc.
ClinicalTrials.gov Identifier: NCT04522999    
Other Study ID Numbers: CSP007
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021

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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
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases