NCT05311514

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: St. Petersburg State Pavlov Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Graft-versus-host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic platelet lysate eye drops	Eye drops

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-11-29
• Completion: 2024-11-29
• First posted: 2022-04-05
• Last updated: 2024-12-04

Locations

1 site across 1 country: Russia