NCT06306690

Biomarkers in Retinitis Pigmentosa

Biomarkers for Prognosis in Different Forms of Retinitis Pigmentosa

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to discover biomarkers that demonstrate a correlation between the severity of retinitis pigmentosa (RP) and the thickness of the retinal pigment epithelium (RPE). These biomarkers will serve as prognostic indicators for various kinds of retinitis pigmentosa. The objective of this study is to find biomarkers that establish a correlation between the severity of retinitis pigmentosa and the thickness of the retinal pigment epithelium (RPE), which can serve as a prognostic indicator for Retinitis Pigmentosa.

Detailed description

After a genetic confirmation of RP and classification, the patients will undergo a comprehensive ophthalmological examination that includes the following tests: slit-lamp anterior segment, visual acuity direct and indirect ophthalmoscopy, intraocular pressure, and family history.In order to evaluate the potential role of RPE in the advancement of RP, HD-OCT and OCT angiography images of the outer retina using OCT devices will be performed. Analysis of high-resolution images captured with an ultrawidefield system using a Zeiss Clarus device in order to determine the condition of the peripheral retina.Finally, Flicker Electroretinogram (fERG) performed on the central retina (macula), to assess the central macular function within an 18° field of view. This assessment involved measuring the response of the macula to a flickering stimulus with a frequency of 41 Hz, which is commonly done in routine clinical practice.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence.	the best visual acuity will be evaluated using decimal tables and then converted to logMar. Ocular fundus examination will be evaluated following pharmacological mydriasis with Tropicamide 1%. OCT will be essential to quantify the central macular thickness and the thickness of the RPE. OCT angiography is a non-invasive method to assess the presence or absence of neovascular membrane and macular flow density. Color and ultra wide field autofluorescence images of the retina will be performed with Zeiss Clarus retinography to search for signs that identify different types of RP and predict their activity and evolution. Electroretinogram flicker (ERG) is a common measure of cone pathway function that is used to study the normal visual system and that of patients with inherited and acquired retinal dysfunction Measurements will be performed using an electrophysiological recording system (CSO). Intermittent stimuli are presented using a Ganzfeld dome (CSO).

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: Italy