Microcurrent Stimulation for Age-Related Macular Degeneration

(i-SIGHT Trial)

No longer recruiting at 9 trial locations

Overseen By Caesar Luo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: i-Lumen Scientific, Inc.

Disqualifiers: Exudative AMD, Diabetic retinopathy, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called transpalpebral microcurrent stimulation (MCS) for individuals with dry age-related macular degeneration (AMD), a condition that affects vision. Researchers aim to determine if this therapy, using a device called i-Lumen(TM) AMD, is safe and effective. The trial includes two groups: one will receive the active treatment, while the other will receive a sham (fake) treatment for comparison. Suitable participants have been diagnosed with dry AMD at the intermediate or geographic atrophy stage and have certain levels of vision in both eyes. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for AMD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that transpalpebral microcurrent stimulation therapy is safe for patients with age-related macular degeneration?

Research has shown that the i-Lumen AMD device, used for microcurrent stimulation therapy, has been tested for safety in people with age-related macular degeneration (AMD). This therapy uses tiny electrical currents through the eyelid and is generally well-tolerated by patients.

Previous studies have not identified major safety concerns. As a non-invasive therapy, serious side effects are unlikely. Participants have not reported significant negative effects, suggesting the treatment is safe for most people.

Although the treatment remains under study, the absence of serious safety issues in earlier research offers reassurance for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the i-Lumen™ AMD treatment because it offers a novel approach to tackling age-related macular degeneration (AMD). Unlike standard treatments like anti-VEGF injections, which target blood vessel growth in the eye, i-Lumen™ uses microcurrent stimulation therapy. This technique involves applying small electrical currents through the eyelid, aiming to improve retinal cell function and preserve vision. This non-invasive method could potentially offer a safer and more comfortable alternative for patients, with the added benefit of possibly enhancing the eye's natural repair processes.

What evidence suggests that transpalpebral microcurrent stimulation is effective for age-related macular degeneration?

Research suggests that transpalpebral microcurrent stimulation (MCS) therapy might improve vision or slow the progression of dry age-related macular degeneration (AMD). Some participants in this trial will receive the active i-Lumen AMD treatment, which uses tiny electrical currents applied through the eyelid and may benefit people with this condition. This non-invasive treatment aims to enhance the eyes’ natural healing abilities. Although not all evidence is conclusive, early findings indicate it could be a helpful option for those with AMD. ^{1 2 3 4 6}

Who Is on the Research Team?

Meredith Mundy

Principal Investigator

i-Lumen Scientific, Inc.

Are You a Good Fit for This Trial?

This trial is for people over 50 with a condition called dry age-related macular degeneration (AMD), specifically at an intermediate stage. Participants must have certain levels of vision in both eyes and cannot be current or heavy past smokers, nor can they have other eye conditions like wet AMD, diabetic retinopathy, or glaucoma.

Inclusion Criteria

I am 50 years old or older.

I have intermediate age-related macular degeneration.

I am 50 years old or older.

Exclusion Criteria

I have wet age-related macular degeneration in at least one eye.

I have or had diabetic retinopathy in at least one eye.

I have glaucoma in one of my eyes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Loading Treatment

Participants undergo initial 5-day loading treatment sessions with microcurrent stimulation therapy

1 week

5 visits (in-person)

Maintenance Treatment

Participants receive two days of maintenance treatments

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• i-Lumen(TM) AMD
• i-Lumen(TM) AMD Sham

Trial Overview

The i-SIGHT trial is testing the safety and effectiveness of a treatment called transpalpebral microcurrent stimulation therapy using a device named i-Lumen(TM) AMD. Some participants will receive the actual therapy while others get a sham (fake) treatment to compare results.

How Is the Trial Designed?

Group I: i-Lumen AMD Active Experimental Treatment 1 Intervention

Active transpalpebral microcurrent stimulation therapy

Group II: i-Lumen AMD Sham Placebo Group 1 Intervention

Sham transpalpebral microcurrent stimulation therapy

Who Is Running the Clinical Trial?

i-Lumen Scientific, Inc.

Lead Sponsor

Trials

4

Recruited

600+

Published Research Related to This Trial

The Rexon-Eye device, using Quantum Molecular Resonance electrotherapy, significantly improved symptoms and clinical signs of mixed-type dry eye disease in 18 patients over 4 weeks, with notable improvements in subjective assessments and objective measures like tear break-up time and meibomian gland function.

No adverse events were reported, indicating that the treatment is safe, and it effectively reduced inflammation markers, suggesting a potential mechanism for its therapeutic action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of Quantum Molecular Resonance (QMR) electrotherapy in mixed-type dry eye patients. Trivli, A., Karmiris, E., Dalianis, G., et al.[2023]

The IRay low voltage treatment system demonstrated an average targeting accuracy of 0.6 mm from the fovea in human cadaver eyes, indicating precise delivery of treatment for age-related macular degeneration (AMD).

The system was able to safely avoid the optic nerve during treatment, with the dose delivered to the fovea matching the prescribed levels, suggesting both safety and efficacy in targeting AMD lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic targeting and dose verification for age-related macular degeneration. Gertner, M., Chell, E., Pan, KH., et al.[2019]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06662162

Microcurrent Stimulation Therapy for Intermediate to ...

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 ...

2.

withpower.com

withpower.com/trial/phase-age---related-macular-degeneration-amd-3-2022-1fe55

Microcurrent Stimulation for Age-Related Macular ...

This trial evaluates a therapy that uses tiny electrical currents through the eyelid to help patients with dry age-related macular degeneration.

3.

ceruleaclinicaltrials.org.au

ceruleaclinicaltrials.org.au/trials/isight2-ilumen/

iSight2 (iLumen)

The purpose of this research study is to assess the safety and effectiveness of the i-Lumen AMD device and see how ongoing treatments may improve vision and may ...

4.

app.trialscreen.org

app.trialscreen.org/trials/microcurrent-stimulation-therapy-intermediate-to-advanced-nonexudative-trial-nct06662162

Microcurrent Stimulation Therapy for Intermediate to ...

Benefits: Participation in this study may help improve your vision or slow the progression of AMD through a non-invasive microcurrent therapy. Your involvement ...

5.

clinconnect.io

clinconnect.io/trials/NCT05447650

Microcurrent Stimulation Therapy for Nonexudative

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

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05703867

NCT05703867 | Transpalpebral Microcurrent Stimulation ...

The goal of this clinical trial is to evaluate the effectiveness of transpalpebral microcurrent stimulation as a therapy for dry age-related macular ...