CB-PRP in Retinitis Pigmentosa and Dry Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The study will provides the enrollment of patients with genetic retinal dystrophies with primary rod impairment and dry age-related macular degeneration (Geographic type) 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 patients 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. Patients affected by bilateral dry age-related macular degeneration (Geographic type) will be recruited as well. After selecting the patients to be enrolled, the study will proceed with the vitrectomy surgery and 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 Electroretinogram (ERG) Visually evoked potential (VEP) contrast sensitivity (MARS tables) Goldmann perimetry Some morpho-functional data will also be collected in the contralateral eye and used as the 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.

Official Title
-----------------
Cord Blood Platelet-rich Plasma (CB-PRP) in Retinitis Pigmentosa and Dry Age-related Macular Degeneration

Conditions
-----------------
Retinitis Pigmentosa, Dry Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Biological: Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Retinal dystrophies with compromised rods (only for RP patients) Visual Field (Manual Goldmann) V / 4e < 30 ° (only for RP patients) Best corrected visual acuity > Light perception Known genotype No or minimal opacity of ocular media No concomitant ocular (eg glaucoma, amblyopia) Dry Age-related Macular Degeneration (Geographic type) Exclusion Criteria: Age<18 years Pregnancy Previous inflammatory / infectious events involving the eyes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Affected Individual<br>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. | Biological: Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) morphological changes | Differences in structural optical coherence tomography (OCT) and OCT Angiography (OCTA) images | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cord blood platelet-rich plasma, Retinitis pigmentosa, Dry Age-related Macular degeneration, Macular Geographic Atrophy