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Completed

NCT Number: NCT05311514

Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease

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.

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Key information

Conditions

Ocular Graft-versus-host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Dry Eye Syndromes Eye Diseases Graft vs Host Disease Immune System Diseases Lacrimal Apparatus Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, 197089, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allogeneic platelet lysate eye drops

Biological

Eye drops

Primary outcomes

  1. Response of ocular chronic GVHD

    Time frame: 2 years

    Measured by 2015 NIH response criteria

Secondary outcomes

  1. Ocular adverse events

    Time frame: 2 years

    Local ocular adverse events measured by CTCAE v5.0.

  2. Tear film breakup time

    Time frame: 2 years

    Measured by fluorescein staining of the tear film

  3. Area of epithelial damage

    Time frame: 2 years

    Measured by fluorescein staining of the ocular surface by the Oxford grading scale (grades 0-5 with increasing severity with higher grades)

  4. 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

    Ocular Surface Disease Index (OSDI) questionnaire.

Sponsors and collaborators

Lead sponsor

St. Petersburg State Pavlov Medical University

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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