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

Ocular Graft-versus-host Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311514
• Other study ID #: 15/21-n
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2022
• Source: St. Petersburg State Pavlov Medical University
• Contact: Natalya V Chistyakova, PhD
• Phone: +79217558218
• Email: nchistik[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Graft vs Host Disease
• Ocular Graft-versus-host Disease

Intervention

Biological:
• Allogeneic platelet lysate eye drops
Eye drops

Locations

Country	Name	City	State
Russian Federation	First Pavlov State Medical University of St. Petersburg	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response of ocular chronic GVHD	Measured by 2015 NIH response criteria	2 years
Secondary	Ocular adverse events	Local ocular adverse events measured by CTCAE v5.0.	2 years
Secondary	Tear film breakup time	Measured by fluorescein staining of the tear film	2 years
Secondary	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
Secondary	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