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Completed

NCT Number: NCT04636853

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alfonso Savastano

Rome, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)

Biological

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.

Primary outcomes

  1. Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) morphological changes

    Time frame: 3 years

    Differences in structural optical coherence tomography (OCT) and OCT Angiography (OCTA) images

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: SiCord

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2020
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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