Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease
Primary Purpose
Ocular Graft-versus-host Disease
Status
Recruiting
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Allogeneic platelet lysate eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Graft-versus-host Disease focused on measuring Chronic Graft-versus-host Disease, Ocular, Dry eye, Allogeneic stem cell transplantation, Platelet lysate, Eye drops
Eligibility Criteria
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.
Sites / Locations
- First Pavlov State Medical University of St. PetersburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Allogeneic Platelet Lysate eye drops 50%
Allogeneic Platelet Lysate eye drops 20%
Arm Description
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
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
Outcomes
Primary Outcome Measures
Response of ocular chronic GVHD
Measured by 2015 NIH response criteria
Secondary Outcome Measures
Ocular adverse events
Local ocular adverse events measured by CTCAE v5.0.
Tear film breakup time
Measured by fluorescein staining of the tear film
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)
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.
Full Information
NCT ID
NCT05311514
First Posted
October 1, 2021
Last Updated
April 4, 2022
Sponsor
St. Petersburg State Pavlov Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05311514
Brief Title
Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Petersburg State Pavlov Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Graft-versus-host Disease
Keywords
Chronic Graft-versus-host Disease, Ocular, Dry eye, Allogeneic stem cell transplantation, Platelet lysate, Eye drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic Platelet Lysate eye drops 50%
Arm Type
Experimental
Arm Description
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
Arm Title
Allogeneic Platelet Lysate eye drops 20%
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Allogeneic platelet lysate eye drops
Intervention Description
Eye drops
Primary Outcome Measure Information:
Title
Response of ocular chronic GVHD
Description
Measured by 2015 NIH response criteria
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Ocular adverse events
Description
Local ocular adverse events measured by CTCAE v5.0.
Time Frame
2 years
Title
Tear film breakup time
Description
Measured by fluorescein staining of the tear film
Time Frame
2 years
Title
Area of epithelial damage
Description
Measured by fluorescein staining of the ocular surface by the Oxford grading scale (grades 0-5 with increasing severity with higher grades)
Time Frame
2 years
Title
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.
Description
Ocular Surface Disease Index (OSDI) questionnaire.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalya V Chistyakova, PhD
Phone
+79217558218
Email
nchistik@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan S Moiseev, MD, Prof.
Phone
+78123386265
Email
moisiv@mail.ru
Facility Information:
Facility Name
First Pavlov State Medical University of St. Petersburg
City
Saint-Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalya V Chistyakova, PhD
Phone
+79217558218
Email
nchistik@mail.ru
First Name & Middle Initial & Last Name & Degree
Ivan S Moiseev, Prof
Phone
+78122334551
Email
coordinatorbmt@gmail.com
First Name & Middle Initial & Last Name & Degree
Natalya V Chistyakova, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
15 years
IPD Sharing 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.
IPD Sharing URL
https://www.1spbgmu.ru/ru/92-glavnaya/nauka/sovety-i-komissii/eticheskij-komitet
Learn more about this trial
Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease
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