Micropulsed laser treatment for macular edema in retinal dystrophies
Treatment of Macular Oedema in Patients With Hereditary Retinal Dystrophies by Applying the Micropulsed Subthreshold Laser
This study is testing a new type of laser treatment to see if it can help reduce swelling in the eyes of people with inherited retinal diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione G.B. Bietti, IRCCS Academic / other |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT05976139 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a confirmed genetic diagnosis of inherited retinal disease and persistent macular edema despite prior treatments.
Not a fit: Patients with retinal dystrophies of unproven genetic origin, diabetes, or those who have had cataract surgery within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve visual acuity and retinal function in patients suffering from macular edema due to inherited retinal dystrophies.
How similar studies have performed: While there have been various treatments for macular edema, the use of micropulsed laser is a novel approach that has not been extensively tested in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome, RM
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.