Safety Results for Geographic Atrophy Associated with Age-Related Macular Degeneration Using Subretinal Cord Blood Platelet-Rich Plasma

Abstract

PurposeTo 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). DesignInterventional, open-label study started in January 2021 with at 12 months of follow-up (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). Subjects, Participants, and ControlsThirteen 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. InterventionAll 13 eyes received 23-gauge (G) vitrectomy and subretinal injection of CB-PRP using a 41-G needle. Main Outcomes and MeasuresBest corrected visual acuity (BCVA) with Early Treatment Diabetic Retinopathy Study (ETDRS) letters, central macular thickness using optical coherence tomography (OCT) and atrophic area measured on en-face OCT images were assessed at baseline, 1, 3, 6 and 12 months. ResultsThe 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 (two-way ANOVA: interaction of treatment by eye or time, p= -0.084). Central macular thickness (CMT) did not show a significant inter-eye 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. ConclusionsSubretinal 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 in order to understand whether the CB-PRP could have a role in the GA treatment.