Lutein by Scleral Iontophoresis in AMD

Launched by FEDERICO II UNIVERSITY · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment method using a medical device that delivers lutein—a nutrient important for eye health—through a technique called iontophoresis. This method is being tested on adults who have been diagnosed with stage 3 age-related macular degeneration (AMD), which affects the central part of the retina and can lead to vision loss. The goal is to see how well this treatment works, how safe it is, and how comfortable participants feel during the process.

To participate in the trial, individuals must be at least 55 years old and have stage 3 AMD in one or both eyes. They must also be in general good health, with specific eye health criteria such as a certain level of vision and eye pressure. Participants will be expected to attend follow-up visits and cooperate with the study procedures. It's important to note that certain conditions, such as recent eye surgeries or specific health issues, may disqualify someone from participating. If you're considering enrolling, this trial aims to explore a potential new way to support eye health in those dealing with AMD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects (male or female) aged ≥ 55 years; Subject able to provide Informed Consent, in compliance with good clinical practice and current legislation
• Subject with age-related macular degeneration (AMD) category 3 in one or both eyes classified according to the criteria reported by "Age-Related Eye Disease Study (AREDS)" based on clinical manifestations:
• • Subject in good general health; Manifest spherical equivalent refraction between +4.0 diopters (D) and - 4.0 D; Best corrected visual acuity (BCVA) for glasses ≤ 0.1 LogMAR; Intraocular pressure (IOP) ≤ 20 mmHg; Subjects able to cooperate with the Investigator; Subjects able to meet the requirements of the entire clinical investigation; Subject who qualifies for treatment with Iontoretina according to the approved indication;
• Exclusion Criteria:
• • Ocular surgery or other type of invasive intervention within the previous 3 months (of any type, including laser surgery and intravitreal injections) performed on the study eye; Lesions, scars, or abrasions of the ocular components present in the eye under study; Dense opacities of the ocular components of the study eye; Implantation of intraocular lenses (IOLs) in the study eye; Congenital malformations in the study eye; Medical history of ocular hypertension and glaucoma, macular pucker, optic neuropathy, diabetic retinopathy, dry eye syndrome, etc. (limited to the study eye);
• • Lutein or zeaxanthin supplementation or any supplementation or with the intention of impacting eye health within the last 4 weeks prior to the screening visit; Known or potential allergy or hypersensitivity and/or history of allergic reactions to any of the components of the medical device or other chemically closely related substances; Subject suffering from type I diabetes, or with a previous case of stroke; Subject suffering from uncontrolled hypertension and heart disease that, in the opinion of the Investigator, does not allow participation in the study or could compromise the results; Subject smoker (more than 20 cigarettes per day); Significant alcohol consumption: more than 2 drinks per day;
• Women of childbearing potential will be excluded from participation in the study if they meet any of the following conditions:
• • pregnant; intend to become pregnant during the study treatment period; Concomitant hormone replacement therapy for menopause. Participation in another clinical study within the previous 90 days; Subject unable to follow clinical investigation procedures and follow-up visits;