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

Phase 2

Completed

• Conditions: Ocular Graft-versus-host Disease
• Interventions: Biological: Allogeneic platelet lysate eye drops

• Registration Number: NCT05311514
• Lead Sponsor: St. Petersburg State Pavlov Medical University

Brief 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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-05
• Status Verified: 2024-11
• Primary Completion: 2024-11-29
• Study Completion: 2024-11-29
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allogeneic Platelet Lysate eye drops 20%	Allogeneic platelet lysate eye drops	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
Allogeneic Platelet Lysate eye drops 50%	Allogeneic platelet lysate eye drops	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

Primary Outcome Measures

Name	Time	Method
Response of ocular chronic GVHD	2 years	Measured by 2015 NIH response criteria

Secondary Outcome Measures

Name	Time	Method
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.	2 years	Ocular Surface Disease Index (OSDI) questionnaire.
Ocular adverse events	2 years	Local ocular adverse events measured by CTCAE v5.0.
Tear film breakup time	2 years	Measured by fluorescein staining of the tear film
Area of epithelial damage	2 years	Measured by fluorescein staining of the ocular surface by the Oxford grading scale (grades 0-5 with increasing severity with higher grades)

Trial Locations

Locations (1)

First Pavlov State Medical University of St. Petersburg; 🇷🇺 Saint-Petersburg, Russian Federation