Stage 3 AMDNCT06925893
Lutein by Scleral Iontophoresis in AMD
An observational study of Stage 3 AMD, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Stage 3 AMD
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects (male or female) aged ≥ 55 years; 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;
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Federico II University
Naples, 80100
Ciro Costagliola, Director Of Ophthalmology Unit, 00390817462394, ciro.costagliola@unina.it
About this study
Official title: Lutein by Scleral Iontophoresis in Patients With Stage 3 Age-Related Macular Degeneration
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.
Read the detailed description
Lutein is a dietary carotenoid which, together with its isomer zeaxanthin, is the main component of the macular pigment of the retina.
Clinical studies have shown that prolonged oral lutein supplementation is safe and is associated with a reduction in the risk of progression from early to advanced stages of Age-Related Macular Degeneration (AMD). However, patient compliance, due to daily oral intake of lutein tablets for a prolonged period of life, is still limited. Additionally, an obstacle to oral supplementation is the variable absorption of lutein through the digestive route.
An iontophoresis method for conveying substances into the eye has been known for some time and already used in the treatment of keratoconus. In this case the substance conveyed is Riboflavin.
A medical device is now available with the following intended use: to combat all oxidative pathologies of the retina and macula, and in particular in the prevention of AMD and in the management of the patient during the evolution of the pathology.
The device consists of an iontophoresis system with scleral applicator and an ophthalmic liquid lutein solution, both of which have already obtained the CE mark. The system therefore includes a generator called K-IONO (CE in class IIa) and a kit called IONTORETINA, which includes a sterile 2 ml vial of lutein (CE in class IIb), the forward and return electrode . which consists of a scleral iontophoresis applicator and an ophthalmic liquid solution of lutein. The topical application of lutein has the advantage of improving the patient's compliance with lutein supplementary therapy compared to oral intake of the carotenoid; Furthermore, in situ application would allow high (therapeutic) concentrations of lutein to be reached in the macular area in a very short period of time (hours) compared to oral intake (months). Publicly available clinical data on scleral iontophoresis or lutein supplementation have not demonstrated any safety-related adverse events and at the same time have demonstrated a reduction in the cumulative risk of progression of AMD from intermediate to advanced stages of the disease.
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
- Stage 3 AMD
- Keywords
- Lutein, AMD, Ionto retina
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA changes [Time Frame: 12 months] Changes in best distance-corrected visual acuity (BCVA) at the End of Study Visit compared to baseline.
Measured: 6 months
Secondary outcomes (1)
BCVA changes [Time Frame: 3, 6 and 12 monhs] Changes in best distance-corrected visual acuity (BCVA) at scheduled controls (Visit 3, Visit 4, Visit 5, and Visit 6) compared to baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Nov 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 3 AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Costagliola, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925893
- Sponsor's protocol ID
- 05809854 Federico II
- Other IDs
- Federico II university
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lutein by Scleral Iontophoresis in Patients With Stage 3 Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT06925893
- Acronym / sponsor ID
- 05809854 Federico II
- Conditions
- Stage 3 AMD
- Keywords
- Lutein, AMD, Ionto retina
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lutein is a dietary carotenoid which, together with its isomer zeaxanthin, is the main component of the macular pigment of the retina.
Clinical studies have shown that prolonged oral lutein supplementation is safe and is associated with a reduction in the risk of progression from early to advanced stages of Age-Related Macular Degeneration (AMD). However, patient compliance, due to daily oral intake of lutein tablets for a prolonged period of life, is still limited. Additionally, an obstacle to oral supplementation is the variable absorption of lutein through the digestive route.
An iontophoresis method for conveying substances into the eye has been known for some time and already used in the treatment of keratoconus. In this case the substance conveyed is Riboflavin.
A medical device is now available with the following intended use: to combat all oxidative pathologies of the retina and macula, and in particular in the prevention of AMD and in the management of the patient during the evolution of the pathology.
The device consists of an iontophoresis system with scleral applicator and an ophthalmic liquid lutein solution, both of which have already obtained the CE mark. The system therefore includes a generator called K-IONO (CE in class IIa) and a kit called IONTORETINA, which includes a sterile 2 ml vial of lutein (CE in class IIb), the forward and return electrode . which consists of a scleral iontophoresis applicator and an ophthalmic liquid solution of lutein. The topical application of lutein has the advantage of improving the patient's compliance with lutein supplementary therapy compared to oral intake of the carotenoid; Furthermore, in situ application would allow high (therapeutic) concentrations of lutein to be reached in the macular area in a very short period of time (hours) compared to oral intake (months). Publicly available clinical data on scleral iontophoresis or lutein supplementation have not demonstrated any safety-related adverse events and at the same time have demonstrated a reduction in the cumulative risk of progression of AMD from intermediate to advanced stages of the disease.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects (male or female) aged ≥ 55 years; 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;
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BCVA changes [Time Frame: 12 months] Changes in best distance-corrected visual acuity (BCVA) at the End of Study Visit compared to baseline.
Time frame: 6 months
1 secondary outcome
BCVA changes [Time Frame: 3, 6 and 12 monhs] Changes in best distance-corrected visual acuity (BCVA) at scheduled controls (Visit 3, Visit 4, Visit 5, and Visit 6) compared to baseline
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage 3 AMD, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ciro Costagliola, Director Of Ophthalmology Unit (+390817462394, ciro.costagliola@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA changes [Time Frame: 12 months] Changes in best distance-corrected visual acuity (BCVA) at the End of Study Visit compared to baseline. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.