CB-PRP in Retinitis Pigmentosa

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    20
  • sponsor
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Updated on 27 January 2021

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.

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.

Details
Condition Retinitis Pigmentosa
Treatment Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)
Clinical Study IdentifierNCT04636853
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Retinitis Pigmentosa??
Retinal dystrophies with compromised rods
Visual Field (Manual Goldmann) V / 4e < 30
Best corrected visual acuity > Light perception
Known genotype
No or minimal opacity of ocular media
No concomitant ocular (eg glaucoma, amblyopia)

Exclusion Criteria

Age<18 years
Pregnancy
Previous inflammatory / infectious events involving the eyes
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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