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Clinical trial

CB-PRP in Retinitis Pigmentosa (SiCord)

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Last updated:16th Dec 2020
Status: Recruiting
Identifier: NCT04636853
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

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