Using Lutein with Iontophoresis for Age-Related Macular Degeneration
Lutein by Scleral Iontophoresis in Patients With Stage 3 Age-Related Macular Degeneration
This study is testing a new way to deliver lutein directly into the eyes of adults with stage 3 age-related macular degeneration to see if it helps improve their vision.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT06925893 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the safety, performance, and tolerability of a medical device that uses iontophoresis to deliver lutein directly into the eyes of adults diagnosed with stage 3 age-related macular degeneration (AMD). Lutein, a dietary carotenoid, is essential for retinal health, but traditional oral supplementation has limitations due to patient compliance and absorption issues. The study will utilize a specialized iontophoresis system designed to enhance the delivery of lutein, potentially improving treatment outcomes for patients with AMD. Participants will be monitored for their response to the treatment over the course of the investigation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 55 and older diagnosed with stage 3 AMD in one or both eyes.
Not a fit: Patients who have undergone ocular surgery or invasive interventions within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and compliant method for delivering lutein to patients with AMD, potentially slowing disease progression.
How similar studies have performed: While iontophoresis has been used in other ocular treatments, this specific application for lutein in AMD is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Naples
- Federico II University — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Ciro Costagliola, Director Of Ophthalmology Unit
- Email: ciro.costagliola@unina.it
- Phone: +390817462394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.