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

Phase 3

Completed

• Conditions: Dry Age-related Macular Degeneration; Retinitis Pigmentosa
• Interventions: Biological: Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)

• Registration Number: NCT04636853
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study First Submitted: 2020-11-14
• Study First Submitted QC: 2020-11-14
• Study First Posted: 2020-11-19
• Status Verified: 2020-12
• Study Start: 2020-12-23
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-02
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Affected Individual	Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)	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.

Primary Outcome Measures

Name	Time	Method
Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) morphological changes	3 years	Differences in structural optical coherence tomography (OCT) and OCT Angiography (OCTA) images

Trial Locations

Locations (1)

Alfonso Savastano; 🇮🇹 Rome, Italy