DML Stage 3NCT06465342
LUTEIN BY SCLERAL IONTOPHORESIS IN PATIENTS WITH STAGE 3 AGE-RELATED MACULAR DEGENERATION (AMD)
An observational study of DML Stage 3, run by OFFHEALTH S.p.A..
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 120 years
- Conditions the study is for
- DML Stage 3
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2024to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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 (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;
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- 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.
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);
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- 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;
- 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;
- breastfeeding, or unwilling to use birth control methods that can be considered highly effective for the entire duration of the study;
- 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;
- Any other medical condition that, in the opinion of the Investigator, could affect participation in the clinical investigation or impair its results.
About this study
Official title: PROSPECTIVE MULTICENTER OBSERVATIONAL CLINICAL INVESTIGATION OF LUTEIN USE BY SCLERAL IONTOPHORESIS IN PATIENTS WITH STAGE 3 AGE-RELATED MACULAR DEGENERATION (AMD)
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
- DML Stage 3
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA changes
Changes in best distance-corrected visual acuity (BCVA) at the End of Study Visit compared to baseline.
Measured: 12 months
Secondary outcomes (1)
BCVA changes
Changes in best distance-corrected visual acuity (BCVA) at scheduled controls (Visit 3, Visit 4, Visit 5, and Visit 6) compared to baseline
Measured: 3, 4, 5 and 6 monhs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start12 Jun 2024 (estimated)
- Primary completion12 Sep 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DML Stage 3Studies 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
- OFFHEALTH S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465342
- Sponsor's protocol ID
- IONTO/06/2023
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rinaldi M, Cennamo G, Passaro ML, Chiosi F, Falco F, D'Alessandro A, Strianese D, Costagliola C. Targeting Macular Pigment in Intermediate Age-Related Macular Degeneration: Oral Supplementation Versus Transscleral Iontophoresis in a Prospective Pilot Study. J Clin Med. 2026 Apr 22;15(9):3188. doi: 10.3390/jcm15093188.
PubMed 42122923
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE MULTICENTER OBSERVATIONAL CLINICAL INVESTIGATION OF LUTEIN USE BY SCLERAL IONTOPHORESIS IN PATIENTS WITH STAGE 3 AGE-RELATED MACULAR DEGENERATION (AMD)
- ClinicalTrials.gov ID
- NCT06465342
- Acronym / sponsor ID
- IONTO/06/2023
- Conditions
- DML Stage 3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- OFFHEALTH S.p.A.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (estimated)
- Primary completion
- 12 Sep 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 18 Jun 2024 (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 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (23 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;
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.
1 secondary outcome
BCVA changes
Time frame: 3, 4, 5 and 6 monhs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 42122923Rinaldi M, Cennamo G, Passaro ML, Chiosi F, Falco F, D'Alessandro A, Strianese D, Costagliola C. Targeting Macular Pigment in Intermediate Age-Related Macular Degeneration: Oral Supplementation Versus Transscleral Iontophoresis in a Prospective Pilot Study. J Clin Med. 2026 Apr 22;15(9):3188. doi: 10.3390/jcm15093188.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of DML Stage 3, run by OFFHEALTH S.p.A..
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 14 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA changes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06465342, which also lists 1 linked publication.
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 18 Jun 2024.