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

Primary Purpose

Dry Age-related Macular Degeneration

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
i-Lumen AMD
i-Lumen AMD Sham
Sponsored by
i-Lumen Scientific, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Age-related Macular Degeneration focused on measuring AMD, Dry AMD

Eligibility Criteria

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

Key Inclusion Criteria - Study Eye:

  • Dry AMD diagnosis.

Key Exclusion Criteria - Study Eye:

  • Wet AMD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    i-Lumen AMD Active

    i-Lumen AMD Sham

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.

    Secondary Outcome Measures

    Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.

    Full Information

    First Posted
    August 11, 2020
    Last Updated
    April 6, 2021
    Sponsor
    i-Lumen Scientific, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04511936
    Brief Title
    Microcurrent Stimulation for Dry Age-related Macular Degeneration
    Acronym
    i-SIGHT
    Official Title
    Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    COVID-related delays.
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    January 31, 2022 (Anticipated)
    Study Completion Date
    January 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    i-Lumen Scientific, Inc.

    4. Oversight

    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
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.
    Detailed Description
    Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Age-related Macular Degeneration
    Keywords
    AMD, Dry AMD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    i-Lumen AMD Active
    Arm Type
    Active Comparator
    Arm Title
    i-Lumen AMD Sham
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    i-Lumen AMD
    Intervention Description
    Microcurrent stimulator
    Intervention Type
    Device
    Intervention Name(s)
    i-Lumen AMD Sham
    Intervention Description
    Sham microcurrent stimulator
    Primary Outcome Measure Information:
    Title
    Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.
    Time Frame
    1 Month
    Secondary Outcome Measure Information:
    Title
    Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.
    Time Frame
    1 Month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Key Inclusion Criteria - Study Eye: Dry AMD diagnosis. Key Exclusion Criteria - Study Eye: Wet AMD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Timothy Jackson, MD
    Organizational Affiliation
    King's College London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Microcurrent Stimulation for Dry Age-related Macular Degeneration

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