Microcurrent Stimulation for Age-Related Macular Degeneration

(i-SIGHT Trial)

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

95 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial evaluates a therapy that uses tiny electrical currents through the eyelid to help patients with dry age-related macular degeneration. The goal is to improve eye health by stimulating eye tissues.

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 data supports the effectiveness of the treatment i-Lumen(TM) AMD for age-related macular degeneration?

Research shows that similar treatments using microcurrent stimulation have helped improve vision in patients with age-related macular degeneration. In one study, 61% of patients experienced significant improvements in vision after electrotherapy. ^{1 2 3 4 5}

Is microcurrent stimulation safe for humans?

Research on microcurrent stimulation for macular degeneration suggests it is generally safe for humans, as studies have focused on its safety and effectiveness in treating eye conditions. ^{1 2 4 6 7}

How is the i-Lumen(TM) AMD treatment different from other treatments for age-related macular degeneration?

The i-Lumen(TM) AMD treatment uses microcurrent stimulation, which involves applying small electrical currents to the eye to potentially slow the progression of macular degeneration or improve vision. This approach is unique because it uses electrical stimulation rather than traditional drug therapies or surgical interventions. ^{1 2 8 9 10}

Research Team

Meredith Mundy

Principal Investigator

i-Lumen Scientific, Inc.

Eligibility Criteria

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'm sorry, but I cannot provide a simplified explanation for the criterion "Key" as it is incomplete and lacks context. Please provide more information.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Microcurrent stimulation in the treatment of dry and wet macular degeneration. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Transpalpebral electrotherapy for dry age-related macular degeneration (AMD): an exploratory trial. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Electrotherapeutic device/protocol design considerations for visual disease applications. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Prosthetic Visual Acuity with the PRIMA System in Patients with Atrophic Age-related Macular Degeneration at 4 years follow-up. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical retinal stimulation therapy for age-related macular degeneration. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Stereotactic targeting and dose verification for age-related macular degeneration. [2019]

7. Spain pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of Quantum Molecular Resonance (QMR) electrotherapy in mixed-type dry eye patients. [2023]

8. France pubmed.ncbi.nlm.nih.gov

[Cortical response in age-related macular degeneration (part I). Methodology and subject specificities]. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Threshold suprachoroidal-transretinal stimulation current required by different-size electrodes in rabbit eyes. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

Transcorneal electrical stimulation shows neuroprotective effects in retinas of light-exposed rats. [2022]