Micropulsed laser treatment for macular edema in retinal dystrophies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of subthreshold micropulsed laser treatment in resolving macular edema in patients with inherited retinal dystrophies. Participants will undergo laser treatment and be evaluated at multiple time points over 24 months using comprehensive ophthalmologic examinations, multifocal electroretinograms, and OCT assessments. The primary endpoint is the measurement of central retinal thickness via OCT. The study aims to provide a new therapeutic option for managing macular edema associated with these conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with inherited retinal disease
* Age between 18 and 80 years
* Conclusive molecular genetic study for IRD
* Male or female patient
* Presence of macular oedema assessed by sd-OCT with reduction ≤ 20% after 3 months of diuretics or draining supplements or 4 months after last anti-VEGF or steroid injection
* Phakic and pseudophakic patients
* Central Retinal thickness \> 320 microns in men and \> 305 microns in women
* Informed consent freely granted and acquired before the start of the study
* Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.

Exclusion Criteria:

* Patients with cataract extraction prior to 6 months
* Patients with IOP ≥ 20 mmHg
* Patients with a clinical diagnosis of retinal dystrophy of unproven genetic origin
* Patients with diabetes
* Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration
* Patients with current or previous vitreo-retinal pathology or with indication for vitreo-retinal surgical therapy (tractional oedema)
* Patients with a lack of target fixation at 32 cm
* Pregnant women

Where it's running

• IRCSS Fondazione G:B:Bietti
  Rome, Rm, Italy Recruiting

Study contacts

• Principal investigator: Lucia Ziccardi, MD, PhD — IRCCS Fondazione G.B. Bietti
• Study coordinator: Lucia Ziccardi, MD, PhD
• Email: neuger@fondazionebietti.it
• Phone: +390684009486

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.