Ocular Graft-versus-host DiseasePhase 2NCT05311514
Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease
A Phase 2 study testing Allogeneic platelet lysate eye drops in people with Ocular Graft-versus-host Disease, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ocular Graft-versus-host Disease
- What is being tested?
- Allogeneic platelet lysate eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2021to 29 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197089
About this study
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.
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.
Read the 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
- Being tested
- Allogeneic platelet lysate eye drops
- Keywords
- Chronic Graft-versus-host Disease, Ocular, Dry eye, Allogeneic stem cell transplantation, Platelet lysate, Eye drops
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic platelet lysate eye dropsBiological
Eye drops
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Allogeneic platelet lysate eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of ocular chronic GVHD
Measured by 2015 NIH response criteria
Measured: 2 years
Secondary outcomes (4)
Ocular adverse events
Local ocular adverse events measured by CTCAE v5.0.
Measured: 2 years
Tear film breakup time
Measured by fluorescein staining of the tear film
Measured: 2 years
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)
Measured: 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.
Ocular Surface Disease Index (OSDI) questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Apr 2021
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Graft-versus-host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311514
- Sponsor's protocol ID
- 15/21-n
- Status last verified
- Nov 2024
- First submitted
- 1 Oct 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05311514
- Acronym / sponsor ID
- 15/21-n
- Conditions
- Ocular Graft-versus-host Disease
- Keywords
- Chronic Graft-versus-host Disease, Ocular, Dry eye, Allogeneic stem cell transplantation, Platelet lysate, Eye drops
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Platelet Lysate eye drops 50% | Experimental | Biological: Allogeneic platelet lysate eye dropsPatients with ocular chronic severe graft versus host disease receive 50% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day |
| Allogeneic Platelet Lysate eye drops 20% | Active comparator | Biological: Allogeneic platelet lysate eye dropsPatients with ocular chronic severe graft versus host disease receive 20% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic platelet lysate eye dropsEye drops | Biological | Allogeneic Platelet Lysate eye drops 20%, Allogeneic Platelet Lysate eye drops 50% |
Primary outcome
Response of ocular chronic GVHD
Time frame: 2 years
Measured by 2015 NIH response criteria
4 secondary outcomes
Ocular adverse events
Time frame: 2 years
Tear film breakup time
Time frame: 2 years
Area of epithelial damage
Time frame: 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.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic platelet lysate eye drops in people with Ocular Graft-versus-host Disease, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of ocular chronic GVHD (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.