Status:
COMPLETED
Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Ocular Graft-versus-host Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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. T...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05311514
Start Date
April 1 2021
End Date
November 29 2024
Last Update
December 4 2024
Active Locations (1)
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1
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia, 197089