CB-PRP in Retinitis Pigmentosa and Dry Age-related Macular Degeneration
NCT ID: NCT04636853
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2020-12-23
2021-12-02
Brief Summary
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A complete morpho-functional ophthalmological evaluation will be performed in all patients at each control.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Affected Individual
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Previous inflammatory / infectious events involving the eyes
18 Years
70 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Alfonso Savastano
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Alfonso Savastano
Rome, , Italy
Countries
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References
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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.2019.021. eCollection 2019.
Rizzo S, Savastano MC, Falsini B, Bernardinelli P, Boselli F, De Vico U, Carla MM, Giannuzzi F, Fossataro C, Gambini G, Crincoli E, Ferrara S, Ripa M, Killian R, Rizzo C, Valentini CG, Orlando N, Placidi G, Teofili L, Savastano A. Safety Results for Geographic Atrophy Associated with Age-Related Macular Degeneration Using Subretinal Cord Blood Platelet-Rich Plasma. Ophthalmol Sci. 2024 Jan 24;4(6):100476. doi: 10.1016/j.xops.2024.100476. eCollection 2024 Nov-Dec.
Other Identifiers
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3417
Identifier Type: -
Identifier Source: org_study_id
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