A New Diagnostic Paradigm for Retinitis Pigmentosa Secondary to USH2A Pathogenic Variants

NCT ID: NCT06545253

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2027-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aim of the study is to perform a non-invasive multimodal retinal imaging investigation in a cohort of patients affected by USH2A retinitis pigmentosa (USH2A-RP), in order to develop a new diagnostic paradigm to categorize clinically relevant subgroups. All the procedures will be performed according to normal clinical practice. In addition, a novel quantitative profiling of serum microRNAs will be carried out in order to analyze the clinical importance of microRNA biomarkers in the clinical setting of the disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

USH2A Variant Retinitis Pigmentosa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

USH2A-RP

Patients affected by genetically-confirmed USH2A-RP.

microRNAs analysis

Intervention Type DIAGNOSTIC_TEST

Patients will undergo routinary ophthalmological examination, multimodal retinal imaging and blood sampling

controls

Healthy control subjects

microRNAs analysis

Intervention Type DIAGNOSTIC_TEST

Patients will undergo routinary ophthalmological examination, multimodal retinal imaging and blood sampling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

microRNAs analysis

Patients will undergo routinary ophthalmological examination, multimodal retinal imaging and blood sampling

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

multimodal retinal imaging

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age \>18 years
* genetically confirmed diagnosis of USH2A-RP
* availability of genetic tests to assess the pathogenic variants

Exclusion Criteria

* inability to understand and sign the written informed consent form
* any inflammatory, infectious or degenerative eye disease
* media opacities resulting incompatible with good imaging quality
* uncontrolled systemic, metabolic, autoimmune neuroinflammatory and neurodegenerative disease
* ophthalmologic surgery within the previous six months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maria Lucia Cascavilla

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PNRR-MR1-2023-12378435

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

High Resolution Retinal Imaging
NCT01866371 RECRUITING