CB-PRP in Retinitis Pigmentosa (SiCord)
CB-PRP in Retinitis Pigmentosa (SiCord)
Brief Summary:
The study will provides the enrollment of patients with genetic retinal dystrophies with primary rod impairment.
A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group.
A complete morpho-functional ophthalmological evaluation will be performed in all patient at each control.
Detailed 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-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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 20 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cord Blood Platelet-rich Plasma (CB-PRP) in Retinitis Pigmentosa
Estimated Study Start Date: December 23, 2020
Estimated Primary Completion Date: December 1, 2021
Estimated Study Completion Date: December 1, 2023
Arm:
- Experimental: Affected Individual
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 20 |
| Estimated Study start date | 23 December 2020 |
| Estimated Study Completion Date | 01 December 2023 |