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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
Sponsor:
Information provided by (Responsible Party):
LumiThera, Inc.

Tracking Information
First Submitted Date  ICMJE August 11, 2020
First Posted Date  ICMJE August 21, 2020
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE August 20, 2020
Actual Primary Completion Date August 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2020)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2020)		 ERG function [ Time Frame: 3 months ]
Multifocal ERG (mfERG), Photopic Negative Response (PhNR), Multi-luminance Flicker ERG (ML-FERG) and Fixed-luminance Flicker ERG (FL-FERG).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 18, 2020)
  • ETDRS Visual Acuity [ Time Frame: 3 months ]
    Measurement of Visual function.
  • Mars Contrast Sensitivity [ Time Frame: 3 months ]
    Measurement of Visual function.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration
Official Title  ICMJE An Objective Study to Evaluate the Ability of Photobiomodulation to Improve Electroretinogram Outcomes in Subjects With Dry Age-Related Macular Degeneration
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age Related Macular Degeneration
Intervention  ICMJE Device: Photobiomodulation
The Valeda™ Light Delivery System
Study Arms  ICMJE Experimental: Photobiomodulation
Valeda™ Light Delivery System
Intervention: Device: Photobiomodulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2020)		 15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 13, 2021
Actual Primary Completion Date August 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04522999
Other Study ID Numbers  ICMJE CSP007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party LumiThera, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE LumiThera, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account LumiThera, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP