Biomarkers in Retinitis Pigmentosa

Last updated: March 10, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Retinitis Pigmentosa

Posterior Uveitis

Treatment

OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence.

Clinical Study ID

NCT06306690
6401
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Other retinal diseases such as macular hole, retinal detachment, macularneovascularization.
  • 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.

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence.
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Maria Cristina Savastano

    Roma, 00198
    Italy

    Active - Recruiting

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