Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2)

August 25, 2026 updated by: i-Lumen Scientific AUS PTY LTD

Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.

The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.

Participants will:

  • Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months.
  • Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia
        • Active, not recruiting
        • Cerulea
  • New Zealand
    • Auckland
      • Remuera, Auckland, New Zealand, 1050
        • Recruiting
        • Auckland Eye Limited
        • Contact:
        • Principal Investigator:
          • Riyaz Bhikoo
  • United Kingdom
      • Belfast, United Kingdom
        • Recruiting
        • Queens University Belfast / Belfast City Hospital
        • Contact:
        • Principal Investigator:
          • Tunde Peto
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
        • Principal Investigator:
          • Timothy Jackson, PhD, FRCOphth
      • Middlesex, United Kingdom, HA1 3UJ
        • Recruiting
        • London North West University Healthcare
        • Contact:
        • Principal Investigator:
          • Christiana Dinah, BSc, MB BS, MRes, FRCOphth
      • Sunderland, United Kingdom, SR2 9HP
        • Recruiting
        • Sunderland Eye Infirmary
        • Contact:
        • Principal Investigator:
          • Ajay Kotagiri
  • United States
    • California
      • Poway, California, United States, 92064
        • Recruiting
        • Retina Consultants San Diego
        • Contact:
        • Principal Investigator:
          • Nicholas London, MD
    • Connecticut
      • Manchester, Connecticut, United States, 06042
        • Recruiting
        • Retina Consultants PC
        • Contact:
          • Chris Research Coordinator
          • Phone Number: 860-646-7704 x113
          • Email: cdwy@retinact.com
        • Principal Investigator:
          • Noam Rudnick, MD
    • Illinois
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • University Retina & Macula Associates
        • Contact:
    • Nevada
      • Reno, Nevada, United States, 89502
        • Not yet recruiting
        • Sierra Eye Associates
        • Principal Investigator:
          • Arshad Khanani
        • Contact:
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • Retina Associates of Cleveland
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Conley, MD
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Retina Associates
        • Principal Investigator:
          • Patrick Williams, MD
        • Contact:
      • Tyler, Texas, United States, 75703
        • Recruiting
        • Tyler Retina Research Insitute
        • Principal Investigator:
          • Samuel Minaker, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Presence of at least one large druse >125 microns in diameter due to AMD.
  • BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200])

Key Exclusion Criteria:

  • Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
  • Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
  • Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L).
  • Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
  • Known severe allergy to fluorescein dye.
  • Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa).
  • History of seizure disorders, chronic migraines and/or cluster headaches.
  • History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre.
  • Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.).
  • History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre.
  • GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.
  • History of intravitreal injections for GA (e.g., Syfovre or Izervay).
  • Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.
  • Glaucoma requiring ≥3 medications and/or drops per day, or history of trabeculectomy.
  • History of any kind of intraocular surgery, excluding cataract surgery performed ≥3 months from Screening.
  • History of yttrium aluminium garnet (YAG) laser posterior capsulotomy <1 month from Screening.
  • Visually significant cataracts and/or visually significant posterior capsular opacification.
  • History of amblyopia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active i-Lumen AMD therapy
Active transpalpebral microcurrent therapy
Device: i-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Sham Comparator: Sham i-Lumen AMD therapy
Sham transpalpebral microcurrent therapy
Device: i-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change BCVA from Baseline
Time Frame: Month 3
Mean change in per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.
Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Portion of per-eye Responders
Time Frame: Month 3
1. Difference in proportion of per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) gaining ≥10 letters from Baseline in distance BCVA ETDRS, active vs sham.
Month 3
Mean Change BCVA from Baseline
Time Frame: Month 6
Mean change in per-eye (treated study eye [unilateral] or treated primary study eye [bilateral]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
i-Lumen Scientific AUS PTY LTD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
i-Lumen Scientific, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Meredith Mundy, i-Lumen Scientific, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILS-AMD-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings