What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF injections, photodynamic therapy, and laser therapy. Known side effects of these treatments can include eye pain, increased intraocular pressure, inflammation, and in rare cases, retinal detachment or infection. For treatments similar to Transpalpebral Microcurrent Stimulation (MCS), which aims to enhance cellular activity and retinal function, side effects are generally mild and may include temporary discomfort, tingling, or redness at the site of application. Serious adverse events are uncommon.

What prior FDA approvals exist?

The FDA has approved several treatments for Age-Related Macular Degeneration (AMD) that focus on enhancing cellular activity and retinal function. These include anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin), which inhibit abnormal blood vessel growth and leakage in the retina. Additionally, photodynamic therapy with verteporfin (Visudyne) has been approved to target abnormal blood vessels in the eye. While these treatments differ from Transpalpebral Microcurrent Stimulation (MCS), they share the goal of preserving retinal function and improving visual outcomes in patients with AMD.

What other types of research exist?

Promising novel alternatives to Transpalpebral Microcurrent Stimulation for Age-Related Macular Degeneration patients include: 1) Subretinal prostheses, which have shown feasibility and long-term stability in animal models, 2) Cortical visual prostheses (CVPs), which are advancing with the help of nanotechnology and have entered clinical trials, and 3) Stem cell therapies, which are progressing towards clinical applications for regenerating retinal tissues.

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Device

Microcurrent Stimulation for Age-Related Macular Degeneration (i-SIGHT Trial)

N/A

Recruiting

Research Sponsored by i-Lumen Scientific, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

Age ≥50 years.

Must not have

History and/or evidence of exudative age-related macular degeneration in either eye

History and/or evidence of diabetic retinopathy in either eye

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort around the eye area due to the device application or unexpected reactions from electrical stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

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I am 50 years old or older.

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I have intermediate age-related macular degeneration.

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I am 50 years old or older.

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I have intermediate age-related macular degeneration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have smoked more than half a pack of cigarettes daily in the last 10 years.

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I have advanced dry age-related macular degeneration in one eye.

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I have central vision loss in one eye.

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I have glaucoma in one of my eyes.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Device Effects

Other study objectives

Mean change best corrected distance visual acuity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: i-Lumen AMD ActiveExperimental Treatment1 Intervention

Active transpalpebral microcurrent stimulation therapy

Group II: i-Lumen AMD ShamPlacebo Group1 Intervention

Sham transpalpebral microcurrent stimulation therapy

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Age-Related Macular Degeneration (AMD) include anti-VEGF (vascular endothelial growth factor) injections, photodynamic therapy, and nutritional supplements. Anti-VEGF injections work by inhibiting the growth of abnormal blood vessels in the retina, thereby reducing fluid leakage and vision loss. Photodynamic therapy involves the use of a light-activated drug to destroy abnormal blood vessels. Nutritional supplements, such as those containing vitamins C and E, zinc, and beta-carotene, help slow the progression of AMD by protecting retinal cells from oxidative damage. These treatments are crucial for AMD patients as they target the underlying mechanisms of the disease, aiming to preserve vision and enhance retinal function. Similarly, Transpalpebral Microcurrent Stimulation (MCS) aims to enhance cellular activity and retinal function, potentially offering a novel approach to managing AMD by stimulating the retina and improving its overall health.