Intravitreal Injections of Cord Blood Platelet-Rich Plasma in Dry Age-Related Macular Degeneration: Regenerative Therapy

Abstract

Purpose: Intravitreal injections (IVIs) of umbilical cord blood platelet-rich plasma (CB-PRP) were investigated to assess their safety and efficacy in slowing the progression of atrophy in eyes with late-stage dry age-related macular degeneration (AMD).

Design: Randomized, controlled, prospective study.

Subjects: Patients with AMD aged >65 years and diagnosed with bilateral geographic atrophy were enrolled.

Methods: One eye of each subject received the treatment of intravitreal CB-PRP 0.05 ml, while the fellow eye received a sham injection. Atrophic areas were identified as large choroidal hypertransmission defects (hyperTDs) on en face subretinal pigment epithelium slabs (64-400 μm beneath Bruch's membrane) obtained 0.321 from swept-source OCT angiography scans. The main outcome was the mean annualized growth rate of the square root transformed area measurements in both treated and nontreated eyes.

Main outcome measures: The mean ± standard deviation (SD) square root hyperTD area in the treated eyes was 3.30 ± 0.99 mm at baseline and 3.49 ± 0.98 mm after CB-PRP (IVI). In nontreated eyes, the mean square root hyperTD area was 2.96 ± 0.94 mm at baseline and 3.18 ± 0.94 mm after sham injections.

Results: Twenty-six eyes of 13 patients were included. In treated eyes, the mean ± SD best-corrected visual acuity (BCVA) was 48.92 ± 16.33 letters at baseline and 51.46 ± 12.27 letters at last follow-up. In untreated eyes, BCVA was 67.69 ± 10.89 letters at baseline and 65.38 ± 10.34 letters at last follow-up. The mean follow-up was 258.46 ± 97.54 days. In both groups, no statistically significant difference was observed between the baseline and final BCVA. For treated eyes, the mean annualized growth rate (square root) was 0.275 mm and for nontreated eyes it was 0.321 mm. The annualized growth rate of the hyperTDs in treated eyes was 14.5% lower than that in nontreated eyes (P = 0.007). No adverse events were recorded.

Conclusions: These preliminary data suggest that intravitreal CB-PRP injections might be safe and effective in slowing the progression of atrophy in AMD. Extended follow-up and larger sample sizes are needed to confirm our findings and determine the optimal treatment regimen for this novel treatment option in late-stage dry AMD.

Financial disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: CB-PRP; Cord blood platelet-rich plasma; Dry age-related macular degeneration; En face OCT; Geographic atrophy.

Figure 1

Cord blood platelet-rich plasma syringe preparation: Extraction of CB-PRP from the pool bag to intravitreal injection. A, Collection bag of the 15 pools of cord extracts. B, Sterile syringe with closed connection system with 20 microvials of 0.2-ml content each. C, Microvials filled with 0.2 ml of CB-PRP. D, Vial emptied by aspiration of its contents through a millimeter insulin syringe (orange syringe) and ready for intravitreal injection with 30-gauge needle (yellow needle). E, Intravitreal injection procedure with needle insertion at 3.5 mm from the limbus in pseudophakic eyes and at 4 mm from the limbus in phakic eyes in the inferotemporal sector 0.05 ml of CB-PRP is injected. CB-PRP = cord blood platelet-rich plasma.

Figure 2

Detection and area measurements of large choroidal hyperTDs on en face SS-OCTA structural images. The left columns show en face subRPE slabs with the outline of hyperTD areas on both treated (green frames) and sham-treated (red frames) eyes. The areas of these outlined regions were subsequently quantified for both eyes at baseline and at the last CB-PRP intravitreal therapy. The right columns display color-coded outlines for each individual hyperTD, allowing for clear differentiation among them. For both treated and untreated groups, BCVA at baseline and the last follow-up was reported. BCVA = best-corrected visual acuity; CB-PRP = cord blood platelet-rich plasma; FUP = follow-up; hyperTDs = hypertransmission defects; SS-OCTA = swept-source OCT angiography; subRPE = subretinal pigment epithelium.

Figure 3

Best-corrected visual acuity in treated eyes. The graph showed the BCVA at baseline and follow-up in injected eyes. No statistically significant difference was observed (P = 0.37). BCVA = best-corrected visual acuity.

Figure 4

Best-corrected visual acuity in sham eyes. The graph showed the BCVA at baseline and follow-up in untreated eyes. No statistically significant difference was observed (P = 0.51). BCVA = best-corrected visual acuity.