Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Retinitis Pigmentosa
Type
Interventional
Phase
Phase 3
Design
Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

All patients underwent genetic evaluation and they reported different types of mutations that induce anatomic-functional impairment of the rods. After selecting the patients to be enrolled, the study will proceed with the vitrectomy surgery and a subretinal injection of umbilical cord blood platelet...

All patients underwent genetic evaluation and they reported different types of mutations that induce anatomic-functional impairment of the rods. After selecting the patients to be enrolled, the study will proceed with the vitrectomy surgery and a subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) provided by the Umbilical Cord Bank according to the procedures provided for by the current legislation on blood components for non-transfusion use. A complete ophthalmological examination will be performed at 1, 3, 6 and 12 months. They will include: Anterior segment biomicroscopy direct and indirect ophthalmoscopy ETDRS visual acuity assessment intraocular pressure measurement optical coherence tomography (OCT) OCT Angiography (OCTA) The following assessments will be performed at baseline and at 6 and 12 months. Microperimetry ERG (elettroretinogramma) - PEV (potenziali evocati visivi) contrast sensitivity (MARS tables) Goldmann perimetry The some morpho-functional data will also be collected in the contralateral eye and used as control group. To ensure the best safety for the patient, the first 5 eyes will be separated by a minimum of 20 days in order to observe the post-surgical evolution.

Tracking Information

NCT #
NCT04636853
Collaborators
Not Provided
Investigators
Principal Investigator: Alfonso Savastano Fondazione Policlinico Universitario A. Gemelli, IRCCS