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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04636853
Other study ID # 3417
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 23, 2020
Est. completion date December 2, 2021

Study information

Verified date December 2020
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
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. A complete morpho-functional ophthalmological evaluation will be performed in all patient at each control.

Locations

Country Name City State
Italy Alfonso Savastano Rome

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Valentini CG, Nuzzolo ER, Bianchi M, Orlando N, Iachininoto MG, Pinci P, Teofili L. Cord Blood Platelet Lysate: In Vitro Evaluation to Support the Use in Regenerative Medicine. Mediterr J Hematol Infect Dis. 2019 Jan 1;11(1):e2019021. doi: 10.4084/MJHID.2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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