Clinical trial NCT05311514: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Graft-versus-host Disease
Keywords: Chronic Graft-versus-host Disease
Ocular
Dry eye
Allogeneic stem cell transplantation
Platelet lysate
Eye drops
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Response of ocular chronic GVHD
timeFrame: 2 years
Secondary outcomes:
measure: Ocular adverse events
timeFrame: 2 years
measure: Tear film breakup time
timeFrame: 2 years
measure: Area of epithelial damage
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: First Pavlov State Medical University of St. Petersburg
Study officials:
References: