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

NCT05311514 | Completed Phase 2

• 1 other identifier: 15/21-n
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Graft-versus-host Disease

Keywords

Chronic Graft-versus-host Disease; Ocular; Dry eye; Allogeneic stem cell transplantation; Platelet lysate; Eye drops

Outcome Measures

Primary Outcomes (1)

• Response of ocular chronic GVHD

  Measured by 2015 NIH response criteria

  2 years

Secondary Outcomes (4)

• Ocular adverse events

  2 years

• Tear film breakup time

  2 years

• Area of epithelial damage

  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.

  2 years

Study Arms (2)

Allogeneic Platelet Lysate eye drops 50%

EXPERIMENTAL

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

Allogeneic Platelet Lysate eye drops 20%

ACTIVE COMPARATOR

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

Interventions

Allogeneic platelet lysate eye drops BIOLOGICAL

Eye drops

Allogeneic Platelet Lysate eye drops 20%; Allogeneic Platelet Lysate eye drops 50%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197089, Russia

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-director for science RM Gorbacheva Institute

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: April 5, 2022
• Study Start: April 1, 2021
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 15 years
• Access Criteria: The individual participant data will be available upon request to the Pavlov Ethical Committee with the description of purposes and study plan according to local standard operating procedures.

Locations

RU (1)