ArticleGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2025
Allogeneic fresh frozen plasma eye drops for the treatment of ocular Graft-versus-Host disease: prospective open-label study.
Article in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
11 authors.
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Abstract
purposeTo evaluate the safety and efficacy of allogeneic fresh frozen plasma drops for the treatment of chronic ocular graft-versus-host disease (oGVHD).
methodsIn this prospective open-label institutional study, adult oGVHD patients were administered allogeneic fresh frozen 100% plasma (FFP) eye drops QID or more for 3 months, in addition to the patients' usual treatment. The drops were prepared using a closed sterile tubing system (COL© System, Biomed Device Srl., Italy). The main outcome measures included the Ocular Surface Disease Index (OSDI), corneal fluorescein staining National Eye Institute (NEI) scale, basal tear secretion test, and functional assessment of cancer therapy-bone marrow transplant (FACT-BMT) questionnaire.
resultsThis study included 25 patients (49 eyes). OSDI scores decreased from 53 ± 26 at baseline to 32 ± 22 after 1 month and 30 ± 23 after 3 months (P < 0.0001), and fluorescein staining NEI grade decreased from 7.04 ± 3.51 at baseline to 5.5 ± 3.1 after 1 month (P < 0.0001) and 5.3 + 3.1 after 3 months (baseline to 3 months, P < 0.0001; one month to 3 months, P = 0.64). Mean basal tear secretion was 4.65 ± 3.4 mm at baseline and 6.5 ± 4.7 mm after 3 months (P = 0.002). The FACT-BMT scores did not change significantly from baseline to 3 months (106.3 ± 22 vs. 112 ± 20, P = 0.08). A subset of eight patients who were using scleral or bandage contact lenses concurrently showed significant improvement, and four of them were managed without lenses during the study period. No significant adverse events were noted.
conclusionAllogeneic FFP eye drops are safe and effective in the treatment of chronic oGVHD.
trial registrationThe trial is listed from 10/2020 in the Israeli Ministry of Health Clinical Trials Registry (MOH_2021-09-30_010276).
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