ESCRS - PO316 - Allogeneic Fresh Frozen Plasma For The Treatment Of Ocular Gvhd: Prospective Phase 2 Open-Label Study

Allogeneic Fresh Frozen Plasma For The Treatment Of Ocular Gvhd: Prospective Phase 2 Open-Label Study

Published 2022 - 40th Congress of the ESCRS

Reference: PO316 | Type: Free paper | DOI: 10.82333/2xdj-cb69

Authors: Yoav Nahum* 1 , Vered Yahalom 2 , Ronit Goldman-Levi 3 , Noa Golomb 1 , Eitan Livny 1 , Mali Rubinstein 4 , Moshe Yeshurun 4

1Ophthalmology,Rabin Medical Center,Petach Tikva,Israel, 2Blood Services & Apheresis ,Rabin Medical Center,Petach Tikva,Israel, 3Blood Services & Apheresis,Rabin Medical Center,Petach Tikva,Israel, 4Hematology,Rabin Medical Center,Petach Tikva,Israel

Purpose

To evaluate the safety and efficacy of allogeneic fresh frozen plasma drops as a treatment for chronic ocular graft-versus-host-disease.

Setting

Prospective phase 2 open-label study, Institutional study.

Methods

Adult patients with ocular GVHD following allogeneic bone marrow transplantation treated with allogeneic fresh frozen 100% plasma drops QID or more for 3 months, on top of their usual treatment. The drops were made using a closed and sterile tubing system (COL© system, Biomed Device Srl., Italy). Main outcome measures included OSDI (Ocular Surface Disease Index) questionnaire, Corneal Fluorescein staining NEI (National Eye Institute) grading and FACT-BMT quality of life questionnaire.

Results

The 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). In 47 eyes who had Fluorescein staining (2 did not), NEI Fluorescein staining grade decreased from 7.6±3.3 at baseline, to 5.9±3.6 after 1 month and 5.5+3.1 after 3 months (P<0.0001). FACT-BMT scores did not change from baseline to 3 months (106.3±22 vs. 112±20, P=0.08). One patient experienced irritation after 2 months of treatment, which resolved after being supplied with a new batch of drops. No other adverse events were noted. Significant improvement was seen also in a subset of patients that was using scleral or bandage contact lenses concurrently.

Conclusions

Allogeneic fresh frozen plasma drops are safe and effective in the treatment of patients with chronic ocular GVHD, allowing rehabilitation of the ocular surface while avoiding the inconvenience of drawing autologous blood from the patients. Specifically in GVHD, this therapy has the advantage of not containing anti-self immune factors, unlike autologous blood.