LUTEIN BY SCLERAL IONTOPHORESIS IN PATIENTS WITH STAGE 3 AGE-RELATED MACULAR DEGENERATION (AMD)

NCT06465342 | Not Yet Recruiting

• 1 other identifier: IONTO/06/2023
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the clinical investigation is to evaluate the performance, safety and degree of tolerability resulting from the use of the iontophoresis medical device in adult subjects diagnosed with AMD stage 3 (AREDS classification) in one or both eyes.

Conditions

DML Stage 3

Outcome Measures

Primary Outcomes (1)

• BCVA changes

  Changes in best distance-corrected visual acuity (BCVA) at the End of Study Visit compared to baseline.

  12 months

Secondary Outcomes (1)

• BCVA changes

  3, 4, 5 and 6 monhs

Eligibility Criteria

• Age: 55 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects (male and female), suffering from stage 3 AMD over 55 years of age. 80 eyes belonging to subjects of both sexes who will be recruited with competitive enrollment between the sites involved in the clinical investigation.

You may qualify if:

• Subjects (male or female) aged ≥ 55 years;
• Subject able to provide Informed Consent, in compliance with good clinical practice and current legislation (i.e. subject able to understand the full nature and purpose of the clinical investigation, including any risks and side effects);
• 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;
• Subject willing to perform a consistent dietary plan, dietary supplement, and medication regimen throughout the study;
• Subject able to comply with the requirements of the clinical investigation plan, according to the Investigator;
• Subjects available for the entire period of the study;
• 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;
• Subject who, in the opinion of the Investigator, will draw benefit from this treatment.

You may not qualify if:

• 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);
• Ocular infection or acute or chronic inflammation of the study eye (for example: Herpes simplex infections, corneal virus infections, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye, uveitis, dacryocystitis);
• Concomitant treatments (topical and/or systemic) with medications, dietary supplements, and/or medical devices known to have effects on the eye; (digitoxin, quinoline, chlorpromazine, tamoxifen, thiazide diuretics);
• 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;
• Evidence of severe or uncontrolled systemic disease or any other significant disorder, which in the opinion of the Investigator does not allow participation in the study or could impair the results;
• Subject smoker (more than 20 cigarettes per day);
• Significant alcohol consumption: more than 2 drinks per day;

Sponsors & Collaborators

• OFFHEALTH S.p.A.: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: June 12, 2024
• Primary Completion: September 12, 2025
• Study Completion: December 12, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06