A Randomized, Double-Blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)

103515

A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.

2019-12-20

2022-12-16

2023-02-24

Completed

Early phase I

15

Inclusion Criteria: * Patients diagnosed within 5 years after hematopoietic stem cell transplant for any disease, with any graft and any conditioning regimen with at least one of the following symptoms: 1. Dry eye symptoms partially affecting (requiring lubricant drops \> 3 x per day or punctal plugs, or thermally cauterized puncta) or significantly affecting (special eyeware to relieve pain) activities of daily living (ADL) 2. Unable to work because of ocular symptoms 3. Loss of vision due to keratoconjunctivitis sicca (KCS) * Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual. * Patients who are 18 years of age or older. * Willing and able to provide informed consent. Exclusion Criteria: * Patients who have any other reversible cause for dry eye at the time of accrual. * More than 3 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus * Relapsed malignancy after transplantation * A difference in dryness between both eyes of more than 2 points of the grading provided by the International Dry Eye Workshop (DEWS) 2007 report * Patients who are pregnant or plan to become pregnant while participating in the study. - Patients who are not willing to discontinue the use of any eye drops, with the exception of non-medicated lubricant eye drops (artificial tears). All eye drops (excluding non-medicated lubricant eye drops) must be stopped at least seven days before treatment with pAF. * Inability to comply with the investigational plan and visit schedule for any

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

2023-07-07