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Safety Results for Geographic Atrophy Associated with Age-Related Macular Degeneration Using Subretinal Cord Blood Platelet-Rich Plasma.
Rizzo, Stanislao; Savastano, Maria Cristina; Falsini, Benedetto; Bernardinelli, Patrizio; Boselli, Francesco; De Vico, Umberto; Carlà, Matteo Mario; Giannuzzi, Federico; Fossataro, Claudia; Gambini, Gloria; Crincoli, Emanuele; Ferrara, Silvia; Ripa, Matteo; Killian, Raphael; Rizzo, Clara; Valentini, Caterina Giovanna; Orlando, Nicoletta; Placidi, Giorgio; Teofili, Luciana; Savastano, Alfonso.
Afiliación
  • Rizzo S; Ophthalmology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Savastano MC; Catholic University "Sacro Cuore", Rome, Italy.
  • Falsini B; Consiglio Nazionale delle Ricerche (CNR), Istituto di Neuroscienze, Pisa, Italy.
  • Bernardinelli P; Ophthalmology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Boselli F; Catholic University "Sacro Cuore", Rome, Italy.
  • De Vico U; Catholic University "Sacro Cuore", Rome, Italy.
  • Carlà MM; Catholic University "Sacro Cuore", Rome, Italy.
  • Giannuzzi F; Catholic University "Sacro Cuore", Rome, Italy.
  • Fossataro C; Ophthalmology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Gambini G; Catholic University "Sacro Cuore", Rome, Italy.
  • Crincoli E; Catholic University "Sacro Cuore", Rome, Italy.
  • Ferrara S; Catholic University "Sacro Cuore", Rome, Italy.
  • Ripa M; Ophthalmology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Killian R; Department of Ophthalmology, Centre Hospitalier Intercommunal del Crèteil, France.
  • Rizzo C; Ophthalmology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Valentini CG; Department of Ophthalmology, William Harvey Hospital, East Kent Hospital University NHS Foundation Trust, Ashford, United Kingdom.
  • Orlando N; Ophthalmology Unit, University of Verona, Verona, Italy.
  • Placidi G; Ophthalmology, Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.
  • Teofili L; Department of Diagnostic Imaging, Oncological Radiotherapy and Hematology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Savastano A; Department of Diagnostic Imaging, Oncological Radiotherapy and Hematology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Ophthalmol Sci ; 4(6): 100476, 2024.
Article en En | MEDLINE | ID: mdl-39149709
ABSTRACT

Purpose:

To evaluate the safety of subretinal injection of cord blood platelet-rich plasma (CB-PRP) and its possible effect in eyes affected by geographic atrophy (GA) associated with dry age-related macular degeneration (d-AMD).

Design:

Interventional, open-label study started in January 2021 with follow-up at 12 months (the Si.Cord Study). This study was a single-center, nonrandomized, sequential-assigned clinical trial conducted in Rome, Italy, at Fondazione Policlinico Universitario Agostino Gemelli IRCCS (ClinicalTrials.gov NCT04636853).

Participants:

Thirteen patients (26 eyes) with bilateral d-AMD-related GA were enrolled. One eye from each patient (with more advanced GA) underwent CB-PRP treatment, and the fellow eye was considered the control. All patients participated in follow-up at 12 months. Intervention All 13 eyes received 23-gauge (G) vitrectomy and subretinal injection of CB-PRP using a 41-gauge needle. Main Outcomes and

Measures:

Best-corrected visual acuity (BCVA) with ETDRS letters, central macular thickness using OCT, and atrophic area measured on en face OCT images were assessed at baseline, 1, 3, 6, and 12 months.

Results:

The BCVA in the treated group was 34.46 ± 20.8 ETDRS at baseline, 40.84 ± 20.52 at 1 month, 40.07 ± 20.34 at 3 months, 39.38 ± 19.84 at 6 months, and 35.84 ± 18.38 at 12 months. In the untreated group, the BCVA was 53 ± 21.1 ETDRS letters at baseline, 51.54 ± 20.99 at 1 month, 46.62 ± 19.47 at 3 months, 46.85 ± 18.58 at 6 months, and 43.92 ± 17.97 at 12 months (2-way analysis of variance interaction of treatment by eye or time, P = 0.084). Central macular thickness did not show a significant intereye difference at 12 months (P = 0.97). The atrophic geographic areas tended to increase in both treated and fellow eyes at 12 months (P < 0.0001). No inflammatory reaction, endophthalmitis, retinal detachment, uveitis, or other complications due to the subretinal injection of CB-PRP were observed during the follow-up.

Conclusions:

Subretinal injection of CB-PRP could be safely used for d-AMD in its GA form. Despite its safety, a larger cohort of patients, and probably a new way of administration, will be needed to understand whether the CB-PRP could have a role in the GA treatment. Financial Disclosures Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Ophthalmol Sci Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Ophthalmol Sci Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Países Bajos