Clinical trial NCT06306690: Biomarkers in Retinitis Pigmentosa
Official title: Biomarkers for Prognosis in Different Forms of Retinitis Pigmentosa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinitis Pigmentosa
Keywords: Retinitis Pigmentosa
Retinal degeneration
Multimodal imaging
electroretinography
retinal pigment epithelium and outer retinal atrophy (RORA)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be enrolled at the Ophthalmology department of Fondazione Policlinico Universitario A. Gemelli IRCCS.

Patients with diverse kinds of RP with genetic confirmation, no other retinal disorders, pressure under 25 mmHg for three months, and no corneal surgery in the past year are included.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients who are able to read and sign informed consent
* Patients with Retinitis pigmentosa confirmed by genetic test.
* Patients older than or equal to 18 years of age

Exclusion Criteria:

* Other retinal diseases such as macular hole, retinal detachment, macular neovascularization.
* Corneal surgery in the last 12 months
* Glaucoma with pressure above 25 mmHg in the last three months.
* Best Correct Visual Acuity below 1/10 in at least one eye.

Primary outcomes:
measure: Retinal pigment epithelium changes in Retinitis Pigmentosa.
timeFrame: 14 months
Secondary outcomes:
measure: Retinitis Pigmentosa biomarkers
timeFrame: 14 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Maria Cristina Savastano
Study officials:
References:
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