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Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT) (i-SIGHT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05447650
Recruitment Status : Recruiting
First Posted : July 7, 2022
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
i-Lumen Scientific, Inc.

Brief Summary:
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Dry Age-related Macular Degeneration Nonexudative Age-related Macular Degeneration Device: i-Lumen(TM) AMD Device: i-Lumen(TM) AMD Sham Not Applicable

Detailed Description:

The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.

Up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.
Actual Study Start Date : April 12, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: i-Lumen AMD Active
Active transpalpebral microcurrent stimulation therapy
Device: i-Lumen(TM) AMD
Transpalpebral microcrurrent stimulation

Sham Comparator: i-Lumen AMD Sham
Sham transpalpebral microcurrent stimulation therapy
Device: i-Lumen(TM) AMD Sham
Transpalpebral sham stimulation




Primary Outcome Measures :
  1. Adverse Device Effects [ Time Frame: Through study completion, Month 12 timepoint ]
    Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study


Other Outcome Measures:
  1. Mean change best corrected distance visual acuity [ Time Frame: Through Month 12 timepoint ]
    Mean change from baseline of best corrected distance visual acuity (CDVA) letter score



Information from the National Library of Medicine

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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

Key Inclusion Criteria:

  • Age ≥50 years.
  • Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD
  • Best-corrected distance visual acuity 20/63 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye

Key Exclusion Criteria:

  • History and/or evidence of exudative age-related macular degeneration in either eye
  • History and/or evidence of diabetic retinopathy in either eye
  • Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)
  • Geographic atrophy in the study eye
  • Central chorioretinal atrophy in the study eye
  • Glaucoma in the study eye

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): NCT05447650


Contacts
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Contact: Meredith Mundy 408-440-7049 clinical@i-lumen.com

Locations
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United States, Arizona
Associated Retina Consultants Recruiting
Phoenix, Arizona, United States, 85020
Contact: Hannah Brookins    602-242-4928    hannah.brookins@doctrials.com   
Contact: Gabrielle Santor    602-242-492    gabrielle.santor@doctrials.com   
Principal Investigator: Benjamin Bakall, MD         
United States, California
Bay Area Retina Associates Recruiting
Walnut Creek, California, United States, 94598
Contact: Luis Monslave    925-945-6800    lmonsalve@bayarearetina.com   
Principal Investigator: Caesar Luo, MD         
United States, Pennsylvania
Cumberland Valley Retina Consultants Recruiting
Chambersburg, Pennsylvania, United States, 21740
Contact: Katie Wintersteen    240-651-8161    KatieW@RetinaCare.net   
Principal Investigator: Allen Hu         
Sponsors and Collaborators
i-Lumen Scientific, Inc.
Investigators
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Study Director: Meredith Mundy i-Lumen Scientific, Inc.
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Responsible Party: i-Lumen Scientific, Inc.
ClinicalTrials.gov Identifier: NCT05447650    
Other Study ID Numbers: ILS-AMD-201
First Posted: July 7, 2022    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by i-Lumen Scientific, Inc.:
AMD
Dry AMD
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases