Macular Degeneration Trial, Recruiting NCT05976139 Sponsor: Fondazione G.B. Bietti, IRCCS Condition: Macular Degeneration
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Macular Degeneration Trial, Recruiting

NCT05976139
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 have been diagnosed with an inherited retinal disease (a genetic condition affecting the retina in the back of your eye)
  • You are between 18 and 80 years old
  • You have had genetic testing that clearly confirmed your inherited retinal disease
  • You are male or female
  • You have swelling in the central part of your retina (called macular oedema), confirmed by a scan, and this swelling has not reduced by more than 20% after at least 3 months of water-reducing treatments, or at least 4 months after your last eye injection
  • The thickness of your central retina is above a certain measurement — over 320 microns if you are male, or over 305 microns if you are female (your eye doctor can check this)
  • You still have your natural lens OR you have had it replaced with an artificial one
  • You are willing and able to give your informed consent before the study begins
  • You are able to understand the study instructions and are likely to attend all required appointments and complete all procedures

Who may not be able to join:

  • You had cataract surgery less than 6 months ago
  • Your eye pressure is too high (20 mmHg or above)
  • Your retinal condition has not been confirmed by genetic testing
  • You have diabetes
  • You have certain other eye conditions, such as central serous chorioretinopathy, a blocked retinal vein, or age-related macular degeneration
  • You currently have or have previously had other problems with the jelly-like substance inside your eye (vitreous) or the retina, or you have been advised to have surgery on this part of your eye
  • You are unable to focus your vision on a target at a distance of 32 cm (confirm with trial site)
  • You are pregnant

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 16 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

Principal Investigator: Lucia Ziccardi, MD, PhD, IRCCS Fondazione G.B. Bietti

Phone: +390684009486

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
Fondazione G.B. Bietti, IRCCS
Registry
ClinicalTrials.gov
Start date
6 September 2023
Est. completion
30 July 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

assessment of significative change in retinal oedema 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: 16 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