Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease

Study Overview
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Brief Summary
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The study evaluates the efficacy and safety of allogeneic platelet lysate eye drops in patients with severe ocular graft versus host disease refractory to conventional systemic and local treatments. The corneal staining, conjunctival hyperemia, tear film break up time,Schirmer test and ocular surface disease index will be evaluated before and after allogeneic platelet lysate treatment. The safety of allogeneic platelet lysate treatment will be also assessed.

Detailed Description
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The corneal staining with fluorescein will be assessed using Oxford grading scale. Tear film break up time is the time in seconds taken to appear first dry sport after complete blinking. Fluorescein is instilled into the patient tear film, the tear film is observed under cobalt blue illumination.Schirmer test will be performed without anesthesia. Conjunctival hyperemia will be graded from 0 to 2. The OSDI questinnaire will assess the impact of treatment on the quality of life.

Official Title
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Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Keratoconjunctivitis Sicca Resistant to Traditional Therapy in Patients With Chronic Ocular Graft-versus-host After Allogeneic Hematopoietic Stem Cell Transplantation.

Conditions
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Ocular Graft-versus-host Disease

Intervention / Treatment
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* Biological: Allogeneic platelet lysate eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe ocular chronic graft-versus-host disease (keratoconjunctivitis sicca) after allo-HSCT Schirmer test < 5mm\5min Tear Film Break-up Time < 5sec Corneal staining > II Gr (Oxford grading scale) Ocular Surface Disease Index (OSDI) >30 Resistance to conventional therapy Exclusion Criteria: Karnofsky <30% Other concomitant conditions, which does not allow to adequately assess the condition of the eye surface; Acute bacterial, viral or fungal infection of the eyes at the time of screening; Somatic or mental pathology that does not allow you to sign an informed consent; Keratoconjunctivitis sicca associated with an anomaly of the eyelids.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogeneic Platelet Lysate eye drops 50%<br>Patients with ocular chronic severe graft versus host disease receive 50% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day | Biological: Allogeneic platelet lysate eye drops<br>* Eye drops<br>|
| Active Comparator: Allogeneic Platelet Lysate eye drops 20%<br>Patients with ocular chronic severe graft versus host disease receive 20% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day | Biological: Allogeneic platelet lysate eye drops<br>* Eye drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of ocular chronic GVHD | Measured by 2015 NIH response criteria | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular adverse events | Local ocular adverse events measured by CTCAE v5.0. | 2 years | 
| Tear film breakup time | Measured by fluorescein staining of the tear film | 2 years | 
| Area of epithelial damage | Measured by fluorescein staining of the ocular surface by the Oxford grading scale (grades 0-5 with increasing severity with higher grades) | 2 years | 
| Patient reported outcomes: severity of dry eye syndrome in patients with chronic ocular graft-versus-host and its impact on the quality of life based on 12 questions, score from 0 to 4. | Ocular Surface Disease Index (OSDI) questionnaire. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Graft-versus-host Disease, Ocular, Dry eye, Allogeneic stem cell transplantation, Platelet lysate, Eye drops