Treatment of Macular Oedema in Patients With Hereditary Retinal Dystrophies by Applying the Micropulsed Subthreshold Laser

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to investigate whether subthreshold treatment with micropulsed laser can be effective in resolving macular edema in patients with inherited retinal dystrophy. Visits will be performed after 1, 3, 6, 9, 12, 18, and 24 months after treatment. Laser treatment will be performed on the day of the first visit, and its repetition at subsequent visits between months 3 and 12 will be evaluated. Evaluations of treatment effects will include: * comprehensive ophthalmologic examination * multifocal electroretinogram * OCT examination * OCT-angiography examination * retinography Primary endpoint. \- central retinal thickness, measured by OCT

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCSS Fondazione G:B:Bietti
RECRUITING
Rome
Contact Information
Primary
Lucia Ziccardi, MD, PhD
neuger@fondazionebietti.it
+390684009486
Backup
Federica Petrocchi, Orthoptist
neuger@fondazionebietti.it
+390684009486
Time Frame
Start Date: 2023-09-06
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 10
Treatments
Experimental: inherited retinal dystrophies with macular oedema
Laser treatment will be performed in patients with macular edema in IRD (experimental arm) who:~* underwent treatment with diuretics or nutritional drainage products for 3 months and subsequent 'wash-out' of one month 17,18 and had no reduction in macular oedema, in terms of central retinal thickness, of at least 20% compared with the initial assessment~* they have had an intravitreal injection of anti-VEGF or steroids, and after 3 months there is no reduction in central retinal thickness (CRT) of at least 20% compared to the initial assessment~* have after 3 months a thickness reduction \<10% compared to baseline assessment, following initial treatment with micropulsed laser, and may be candidates for repeating treatment;~* are not eligible for diuretic therapy due to the presence of comorbidities.
Sponsors
Leads: Fondazione G.B. Bietti, IRCCS

This content was sourced from clinicaltrials.gov