Recruiting

i-Lumen AMD

Sponsor:

i-Lumen Scientific AUS PTY LTD

Code:

NCT06662162

Conditions

Age-Related Macular Degeneration

Age-related Macular Degeneration (ARMD)

Intermediate AMD

Geographic Atrophy Secondary to Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

i-Lumen AMD

Study Details

Brief summary:

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.

Conditions

Age-Related Macular Degeneration

Age-related Macular Degeneration (ARMD)

Intermediate AMD

Geographic Atrophy Secondary to Age-related Macular Degeneration

Study ID

NCT06662162

Start date

May 7, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active i-Lumen AMD therapy

Active transpalpebral microcurrent therapy

sham comparator: Sham i-Lumen AMD therapy

Sham transpalpebral microcurrent therapy

Interventions

i-Lumen AMD

i-Lumen AMD transpalpebral microcurrent stimulation system

Primary outcome measure

  • Mean Change BCVA from Baseline [ Time Frame: Month 3 ]

Central Contacts and Locations

Central contacts

Meredith Mundy

408-440-7049mmundy@i-lumen.com

Locations

Retina Consultants San Diego

Recruiting

Poway, California, United States, 92064

Contacts

Research Coordinator

858-451-1911dcarbajal@rcsd.com

Principal Investigator:

Nicholas London, MD

Retina Consultants PC

Recruiting

Manchester, Connecticut, United States, 06042

Contacts

Chris Research Coordinator

860-646-7704 x113cdwy@retinact.com

Principal Investigator:

Noam Rudnick, MD

University Retina & Macula Associates

Recruiting

Lemont, Illinois, United States, 60439

Contacts

Clinical Research Manager

708-765-4110swheatley@uretina.com

Retina Associates of Cleveland

Recruiting

Beachwood, Ohio, United States, 44122

Contacts

Diane Research Coordinator

(216) 831-5700dweiss@retina-assoc.com

Maureen Research Coordinator

(440) 663-0022mcunningham@retina-assoc.com

Principal Investigator:

Joseph Conley, MD

Texas Retina Associates

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Lori Research Coordinator

817-334-0882 x411lmullen@texasretina.com

Principal Investigator:

Patrick Williams, MD

Tyler Retina Research Insitute

Recruiting

Tyler, Texas, United States, 75703

Contacts

Melissa Long Research Coordinator

903-597-4644mlong@tylerretina.com

Principal Investigator:

Samuel Minaker, MD

More Information

Sponsor

i-Lumen Scientific AUS PTY LTD

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • AMD
  • Intermediate AMD
  • Dry AMD
  • Geographic Atrophy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by i-Lumen Scientific AUS PTY LTD on 2026-08-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.