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Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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.

NCT05311514•St. Petersburg State Pavlov Medical University

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, Russia

Key Dates

Start Date

April 1, 2021

Primary Completion Date

November 29, 2024

Completion Date

November 29, 2024

Last Updated

December 4, 2024

Enrollment

ACTUAL participants

Conditions

Ocular Graft-versus-host Disease

Interventions

Allogeneic platelet lysate eye drops

BIOLOGICAL

Electrostimulation Study for Ocular Graft vs. Host Disease

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Chronic Ocular Graft-versus-host Disease

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NOT_YET_RECRUITINGEARLY_PHASE1

A Study of Stem Cells Lenses in the coGVHD Subjects

NCT06952114

Chronic Ocular Graft-versus-host Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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