An observational study in Retinitis Pigmentosa, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
Among 14 studies in Retinitis Pigmentosa with a site in Italy — 4 open to participants now, 6 under way, 1 of them phase 3. Retinitis Pigmentosa · Italy.
Among the 14 studies in Retinitis Pigmentosa with a site in Italy, this one is one of 3 that started in 2024, is one of 5 observational ones, and was the 11th registered.
278 studies on the registry are indexed under Retinitis Pigmentosa; 72 are open to participants now.
This study's planned enrollment of 35 is below the median of 52 across 87 observational studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →4 of the 14 studies in Retinitis Pigmentosa with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 49 Retinitis Pigmentosa studies recruiting now, 37 (76%) set no upper age limit and 7 (14%) stop at 75 or younger; 16 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 3 started in 2024.
Median enrollment 48 across the 8 interventional studies, 120 across the 5 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
7 of 14 have an industry lead sponsor. The 10 most frequent:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS has 2 studies filed under Retinitis Pigmentosa — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Retinitis Pigmentosa with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following a clinical diagnosis, patients undergo genetic testing. Patients with rhodopsin mutation (RHO) a mutation are categorised into subgroup 1.
Diagnostic Test: OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence.
Following a clinical diagnosis, patients undergo genetic testing. Patients with pre-mRNA factor 8 (PRPF8) mutation are categorised into subgroup 2.
Diagnostic Test: OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence.
Following a clinical diagnosis, patients undergo genetic testing. Patients with a cone-specific phosphodiesterase, i.e. PDE6B, mutation are categorised into subgroup 3.
Diagnostic Test: OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence.
Following a clinical diagnosis, patients undergo genetic testing. Patients with Chromosome 2-Open (C2orf71) mutation are categorised into subgroup 4.
Diagnostic Test: OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence.
Following a clinical diagnosis, patients undergo genetic testing. Patients with Guanylate Cyclase (GUCY2D) mutation are categorised into subgroup 5.
Diagnostic Test: OCT, OCT angiography, flicker ERG and Ultra Wide Field retinography and autofluorescence.
Following a clinical diagnosis, patients undergo genetic testing. Patients with RP- specific nuclear receptor (Nr2E3) mutation are categorised into subgroup 6.
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).
Retinal pigment epithelium changes in Retinitis Pigmentosa.
Retinal pigment epithelium extent measured with OCT calliper (micrometers).
Time frame: 14 months
Retinitis Pigmentosa biomarkers
Measurement of retinal pigment epithelium extension by oct calliper (micrometers) in different forms of retinitis pigmentosa. Measurement of superficial and deep retinal vascularisation in the different forms of retinitis pigmentosa.
Time frame: 14 months
Plan to share: Undecided
Started Feb 2024 (actual). Primary completion is estimated for Apr 2025, 14 months after the start.
Of 48 observational studies under Retinitis Pigmentosa, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 28. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
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