Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host… (NCT05311514) | Clinical Trial Compass
CompletedPhase 2
Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease
Russia38 participantsStarted 2021-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response of ocular chronic GVHD
Timeframe: 2 years
Trial details
NCT IDNCT05311514
SponsorSt. Petersburg State Pavlov Medical University