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 range18 Years – 75 Years

SexALL

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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.

What they're measuring

Response of ocular chronic GVHD

Timeframe: 2 years

Trial details

NCT IDNCT05311514

SponsorSt. Petersburg State Pavlov Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-29

View on ClinicalTrials.gov More Ocular Graft-versus-host Disease trials