Intermediate Age-Related Macular Degeneration With Reticular PseudodrusenNCT07420361
Lutein Iontophoresis in Intermediate AMD and Reticular Pseudodrusen - a Retrospective Study
An observational study of Intermediate Age-Related Macular Degeneration With Reticular Pseudodrusen, run by Mario Damiano Toro at 1 site in Italy.
Trial summary
There is limited data available on the efficacy and safety of Transscleral Lutein Iontophoresis (TSLI) in patients with in-termediate age-related macular degeneration (iAMD) and reticular pseudodrusen (RPD). Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Intermediate Age-Related Macular Degeneration With Reticular Pseudodrusen
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2023to 31 Aug 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the regions of Naples and Cagliari
Who may be able to join
- Age between 55 and 80 years old
- diagnosis of early to intermediate stage dAMD (based on AREDS criteria)
- presence of RPD
- Treated with scleral Lutein Iontophoresis
Who cannot join
- GA or MNV in the included eye
- any prior or any ongoing medical or surgical treatment of the included eye (including intravitreal injections, oral supplementation of lutein, zeaxanthin and or high dietary intake of antioxidants)
- smokers (consummation of more than 20 cigarettes per day)
- history of treatment with drugs with a well-known possible ophthalmic side-effect
- known eye diseases such glaucoma, acute or chronic uveitis, advanced cataract, stage 4 dry eye disease or any opacities of the ocular media that do not permit high-quality imaging examinations
- manifest refraction outside of -6 and +4 dioptres
- BCVA < 40 EDTRS letters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Efficacy and Safety of Transcleral Lutein Iontophoresis in Patients With Intermediate Amd and Reticular Pseudodrusen: a Retrospective Study
There is limited data available on the efficacy and safety of Transscleral Lutein Iontophoresis (TSLI) in patients with in-termediate age-related macular degeneration (iAMD) and reticular pseudodrusen (RPD).
This retrospective multicentre study evaluated the functional and morphological outcomes of TSLI in patients with stage 2 and stage 3 iAMD with RPD. Autofluorescence (AF), Optical Coherence Tomography (OCT), Best Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP), Macular Sensitivity (MS) and adverse events, were recorded at baseline, 1 month and 3 months follow-up after treatment.
- Keywords
- transcleral lutein iontophoresis, age related macular degeneration, reticular pseudodrusen
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| transcleral lutein iontophoresis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional parameter
best corrected visual acuity (logMar)
Measured: August 2023 to August 2024
structural parameter over the course of follow-up
Outer retinal morphology using OCT and changes in FAF, specifically RPD type (1-4)
Measured: August 2023 to August 2024
structural parameter over the course of follow-up
Outer retinal morphology using OCT and changes in FAF, specifically ONL thickness (micrometers)
Measured: August 2023 to August 2024
structural parameter over the course of follow-up
Outer retinal morphology using OCT and changes in FAF, specifically choroidal thickness (micrometers)
Measured: August 2023 to August 2024
structural parameter over the course of follow-up
Outer retinal morphology using OCT and changes in FAF, specifically CMT (micrometers)
Measured: August 2023 to August 2024
structural parameter over the course of follow-up
changes in FAF, (descriptive - iso/hyper/hypofluorescent)
Measured: August 2023 to August 2024
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
monitoring of adverse events over the course of the follow up (n)
Measured: August 2023 to August 2024
Secondary outcomes (1)
functional parameter
mean sensitivity (dB)
Measured: August 2023 to August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Aug 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate Age-Related Macular Degeneration With Reticular PseudodrusenStudies 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
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Damiano Toro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Damiano Toro, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420361
- Sponsor's protocol ID
- 273/2024
- Status last verified
- Jul 2025
- First submitted
- 1 Feb 2026
- Last updated
- 19 Feb 2026
- 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy and Safety of Transcleral Lutein Iontophoresis in Patients With Intermediate Amd and Reticular Pseudodrusen: a Retrospective Study
- ClinicalTrials.gov ID
- NCT07420361
- Acronym / sponsor ID
- 273/2024
- Keywords
- transcleral lutein iontophoresis, age related macular degeneration, reticular pseudodrusen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mario Damiano ToroUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 19 Feb 2026 (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.
There is limited data available on the efficacy and safety of Transscleral Lutein Iontophoresis (TSLI) in patients with in-termediate age-related macular degeneration (iAMD) and reticular pseudodrusen (RPD).
This retrospective multicentre study evaluated the functional and morphological outcomes of TSLI in patients with stage 2 and stage 3 iAMD with RPD. Autofluorescence (AF), Optical Coherence Tomography (OCT), Best Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP), Macular Sensitivity (MS) and adverse events, were recorded at baseline, 1 month and 3 months follow-up after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transcleral lutein iontophoresis | – | – |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the regions of Naples and Cagliari
Key inclusion criteria (4 listed)
- Age between 55 and 80 years old
- diagnosis of early to intermediate stage dAMD (based on AREDS criteria)
- presence of RPD
- Treated with scleral Lutein Iontophoresis
Key exclusion criteria (7 listed)
- GA or MNV in the included eye
- any prior or any ongoing medical or surgical treatment of the included eye (including intravitreal injections, oral supplementation of lutein, zeaxanthin and or high dietary intake of antioxidants)
- smokers (consummation of more than 20 cigarettes per day)
- history of treatment with drugs with a well-known possible ophthalmic side-effect
- known eye diseases such glaucoma, acute or chronic uveitis, advanced cataract, stage 4 dry eye disease or any opacities of the ocular media that do not permit high-quality imaging examinations
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
functional parameter
Time frame: August 2023 to August 2024
best corrected visual acuity (logMar)
structural parameter over the course of follow-up
Time frame: August 2023 to August 2024
Outer retinal morphology using OCT and changes in FAF, specifically RPD type (1-4)
structural parameter over the course of follow-up
Time frame: August 2023 to August 2024
Outer retinal morphology using OCT and changes in FAF, specifically ONL thickness (micrometers)
structural parameter over the course of follow-up
Time frame: August 2023 to August 2024
Outer retinal morphology using OCT and changes in FAF, specifically choroidal thickness (micrometers)
structural parameter over the course of follow-up
Time frame: August 2023 to August 2024
Outer retinal morphology using OCT and changes in FAF, specifically CMT (micrometers)
structural parameter over the course of follow-up
Time frame: August 2023 to August 2024
changes in FAF, (descriptive - iso/hyper/hypofluorescent)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: August 2023 to August 2024
monitoring of adverse events over the course of the follow up (n)
1 secondary outcome
functional parameter
Time frame: August 2023 to August 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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.
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 Intermediate Age-Related Macular Degeneration With Reticular Pseudodrusen, run by Mario Damiano Toro 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 19 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
functional parameter (time frame: August 2023 to August 2024). The study lists 7 primary outcomes in all. 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 19 Feb 2026.