NCT05311514CompletedPhase 2
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.
Source: ClinicalTrials.gov · Last updated 4 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 1 Oct 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 29 Nov 2024
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- NCT number
- NCT05311514
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 38
- From 1 Apr 2021 to the primary completion date, 29 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other concomitant conditions, which does not allow to adequately assess the condition of the eye surface;
Other illness
- Acute bacterial, viral or fungal infection of the eyes at the time of screening;
Other
- Karnofsky \<30%
- Somatic or mental pathology that does not allow you to sign an informed consent;
- Keratoconjunctivitis sicca associated with an anomaly of the eyelids.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Pavlov State Medical University of St. Petersburg Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.