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

May 1, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • 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 Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Hobart Eye Surgeons
        • Contact:
        • Principal Investigator:
          • Nitin Verma, MD, MBBS
    • Victoria
      • Adelaide, Victoria, Australia, 5000
        • Recruiting
        • Adelaide Eye & Retina Centre
        • Contact:
        • Principal Investigator:
          • Jagjit Jolly Gilhotra
      • East Melbourne, Victoria, Australia
  • New Zealand
      • Christchurch, New Zealand
        • Recruiting
        • Southern Eye Specialist
        • Principal Investigator:
          • James Borthwick
        • Contact:
    • Auckland
      • Remuera, Auckland, New Zealand, 1050
        • Recruiting
        • Auckland Eye Limited
        • Contact:
        • Principal Investigator:
          • Riyaz Bhikoo
  • United Kingdom
      • 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
    • Connecticut
      • Manchester, Connecticut, United States, 06042
        • Not yet 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
        • Not yet recruiting
        • University Retina & Macula Associates
        • Contact:
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Not yet recruiting
        • Texas Retina Associates
        • Principal Investigator:
          • Patrick Williams, MD
        • Contact:
      • Tyler, Texas, United States, 75703
        • Not yet 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

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
Intervention / Treatment
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

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

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

i-Lumen Scientific AUS PTY LTD

Collaborators

i-Lumen Scientific, Inc.

Investigators

  • Study Director: Meredith Mundy, i-Lumen Scientific AUS PTY LTD

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)

May 7, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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