Intravitreal Injections of Cord Blood Platelet-Rich Plasma in Dry Age-Related Macular Degeneration: Regenerative Therapy
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). Randomized, controlled, prospective study. Patients wit...
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| Published in | Ophthalmology science (Online) Vol. 5; no. 4; p. 100732 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
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Netherlands
Elsevier Inc
01.07.2025
Elsevier |
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| Abstract | 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).
Randomized, controlled, prospective study.
Patients with AMD aged >65 years and diagnosed with bilateral geographic atrophy were enrolled.
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.
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.
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.
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.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. |
|---|---|
| AbstractList | 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).PurposeIntravitreal 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).Randomized, controlled, prospective study.DesignRandomized, controlled, prospective study.Patients with AMD aged >65 years and diagnosed with bilateral geographic atrophy were enrolled.SubjectsPatients with AMD aged >65 years and diagnosed with bilateral geographic atrophy were enrolled.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.MethodsOne 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.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.Main Outcome MeasuresThe 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.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.ResultsTwenty-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.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.ConclusionsThese 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.Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.Financial DisclosuresProprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. 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). Randomized, controlled, prospective study. Patients with AMD aged >65 years and diagnosed with bilateral geographic atrophy were enrolled. 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. 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. 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 ( = 0.007). No adverse events were recorded. 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. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. PurposeIntravitreal 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). DesignRandomized, controlled, prospective study. SubjectsPatients with AMD aged >65 years and diagnosed with bilateral geographic atrophy were enrolled. MethodsOne 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 MeasuresThe 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. ResultsTwenty-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. ConclusionsThese 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 Disclosure(s)Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. 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). Randomized, controlled, prospective study. Patients with AMD aged >65 years and diagnosed with bilateral geographic atrophy were enrolled. 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. 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. 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. 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. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. |
| ArticleNumber | 100732 |
| Author | Rosenfeld, Philip J. Giannuzzi, Federico Teofili, Luciana Fossataro, Claudia Valentini, Caterina Giovanna Carlà, Matteo Mario D'Agostino, Elena Savastano, Alfonso Savastano, Maria Cristina Pirolo, Riccardo Shen, Mengxi Marcelli, Sofia Rizzo, Stanislao Mottola, Francesco Biagini, Ilaria Bianchi, Maria Cusato, Mattia Rizzo, Clara Cheng, Yuxuan Gravina, Alessandro Wang, Ruikang K. Boselli, Francesco Berni, Alessandro Cestrone, Valentina |
| Author_xml | – sequence: 1 givenname: Maria Cristina orcidid: 0000-0003-1397-4333 surname: Savastano fullname: Savastano, Maria Cristina organization: Ophthalmology Unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy – sequence: 2 givenname: Claudia orcidid: 0000-0001-9474-0517 surname: Fossataro fullname: Fossataro, Claudia email: fossataroclaudia@gmail.com organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 3 givenname: Alessandro surname: Berni fullname: Berni, Alessandro organization: Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida – sequence: 4 givenname: Alfonso surname: Savastano fullname: Savastano, Alfonso organization: Ophthalmology Unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy – sequence: 5 givenname: Valentina surname: Cestrone fullname: Cestrone, Valentina organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 6 givenname: Federico surname: Giannuzzi fullname: Giannuzzi, Federico organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 7 givenname: Francesco surname: Boselli fullname: Boselli, Francesco organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 8 givenname: Matteo Mario orcidid: 0000-0003-2979-1638 surname: Carlà fullname: Carlà, Matteo Mario organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 9 givenname: Mattia surname: Cusato fullname: Cusato, Mattia organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 10 givenname: Francesco orcidid: 0009-0002-1091-882X surname: Mottola fullname: Mottola, Francesco organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 11 givenname: Riccardo surname: Pirolo fullname: Pirolo, Riccardo organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 12 givenname: Elena surname: D'Agostino fullname: D'Agostino, Elena organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 13 givenname: Ilaria surname: Biagini fullname: Biagini, Ilaria organization: Ophthalmology Unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy – sequence: 14 givenname: Sofia surname: Marcelli fullname: Marcelli, Sofia organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 15 givenname: Alessandro surname: Gravina fullname: Gravina, Alessandro organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 16 givenname: Mengxi orcidid: 0000-0002-1336-1695 surname: Shen fullname: Shen, Mengxi organization: Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida – sequence: 17 givenname: Clara surname: Rizzo fullname: Rizzo, Clara organization: Ophthalmology, Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy – sequence: 18 givenname: Caterina Giovanna surname: Valentini fullname: Valentini, Caterina Giovanna organization: Division of Hematology, Department of Radiological and Hematological Sciences, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 19 givenname: Maria surname: Bianchi fullname: Bianchi, Maria organization: Division of Hematology, Department of Radiological and Hematological Sciences, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 20 givenname: Luciana surname: Teofili fullname: Teofili, Luciana organization: Ophthalmology Unit, Catholic University “Sacro Cuore”, Rome, Italy – sequence: 21 givenname: Yuxuan orcidid: 0000-0003-1200-727X surname: Cheng fullname: Cheng, Yuxuan organization: Department of Bioengineering, University of Washington, Seattle, Washington – sequence: 22 givenname: Ruikang K. orcidid: 0000-0001-5169-8822 surname: Wang fullname: Wang, Ruikang K. organization: Department of Bioengineering, University of Washington, Seattle, Washington – sequence: 23 givenname: Philip J. orcidid: 0000-0002-4068-6671 surname: Rosenfeld fullname: Rosenfeld, Philip J. organization: Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida – sequence: 24 givenname: Stanislao surname: Rizzo fullname: Rizzo, Stanislao organization: Ophthalmology Unit, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy |
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| Keywords | hyperTD AE CB-PRP Cord blood platelet-rich plasma SD BCVA En face OCT Geographic atrophy AMD Dry age-related macular degeneration GA subRPE IVI adverse event intravitreal injection subretinal pigment epithelium hypertransmission defect best-corrected visual acuity age-related macular degeneration standard deviation |
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| Snippet | Intravitreal injections (IVIs) of umbilical cord blood platelet-rich plasma (CB-PRP) were investigated to assess their safety and efficacy in slowing the... PurposeIntravitreal injections (IVIs) of umbilical cord blood platelet-rich plasma (CB-PRP) were investigated to assess their safety and efficacy in slowing... |
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| SubjectTerms | CB-PRP Cord blood platelet-rich plasma Dry age-related macular degeneration En face OCT Geographic atrophy Ophthalmology Original |
| Title | Intravitreal Injections of Cord Blood Platelet-Rich Plasma in Dry Age-Related Macular Degeneration: Regenerative Therapy |
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