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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05311514

Enrollment

Registered

2022-04-05

Start date

2021-04-01

Completion date

2024-11-29

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Graft-versus-host Disease

Keywords

Chronic Graft-versus-host Disease, Ocular, Dry eye, Allogeneic stem cell transplantation, Platelet lysate, Eye drops

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.

Interventions

BIOLOGICALAllogeneic platelet lysate eye drops

Eye drops

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Response of ocular chronic GVHD	2 years	Measured by 2015 NIH response criteria

Secondary

Measure	Time frame	Description
Ocular adverse events	2 years	Local ocular adverse events measured by CTCAE v5.0.
Tear film breakup time	2 years	Measured by fluorescein staining of the tear film
Area of epithelial damage	2 years	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.	2 years	Ocular Surface Disease Index (OSDI) questionnaire.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026