Macular Degeneration Trial, Recruiting NCT06925893 Sponsor: Federico II University Condition: Macular Degeneration
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Macular Degeneration Trial, Recruiting

NCT06925893
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a man or woman aged 55 or older
  • You are able to understand and sign a consent form agreeing to take part
  • You have been diagnosed with age-related macular degeneration (AMD) at category 3 (an intermediate stage) in one or both eyes, based on a standard eye disease classification system called AREDS
  • You are generally in good health
  • Your glasses prescription is between +4.0 and -4.0 (meaning you have mild to moderate long- or short-sightedness at most)
  • Your vision with glasses is good enough to meet a specific measurement standard (confirm with trial site)
  • The pressure inside your eye is 20 mmHg or below (within a normal range)
  • You are able to work with the study team and attend all required visits
  • You qualify for treatment with the device used in this trial, called Iontoretina (confirm with trial site)

Who may not be able to join:

  • You have had eye surgery, laser treatment, or injections into the eye being studied in the past 3 months
  • You have wounds, scars, or scratches on or in the eye being studied
  • You have significant cloudiness or blockages inside the eye being studied (confirm with trial site)
  • You have an artificial lens implanted in the eye being studied
  • You were born with a structural problem affecting the eye being studied
  • You have a history of high eye pressure, glaucoma, a wrinkling of the retina, optic nerve damage, diabetic eye disease, or chronic dry eye in the eye being studied
  • You have taken lutein, zeaxanthin, or any other supplement intended to support eye health in the past 4 weeks
  • You have a known or possible allergy to any ingredient in the Iontoretina device or closely related substances
  • You have Type 1 diabetes or have previously had a stroke
  • You have high blood pressure or heart disease that is not well controlled
  • You smoke more than 20 cigarettes per day
  • You drink more than 2 alcoholic drinks per day
  • You are a woman who could become pregnant and are currently pregnant, plan to become pregnant during the study, or are currently using hormone replacement therapy for menopause
  • You have taken part in another clinical trial within the past 90 days
  • You are unable to follow the study procedures or attend all follow-up visits

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +390817462394

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Federico II University
Registry
ClinicalTrials.gov
Start date
1 November 2024
Est. completion
1 December 2024

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

BCVA changes [Time Frame: 12 months] Changes in best distance-corrected visual acuity (BCVA) at the End of Study Visit compared to baseline.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov