Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2023-02-24

Brief Summary

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

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Detailed Description

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This is a randomized (to each eye, within patient), double-blinded, placebo-controlled study of the efficacy of Processed Amniotic Fluid (pAF) in patients with hematologic malignancies who have undergone Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and are diagnosed with Chronic Graft Verses Host Disease of the eye.

Conditions

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Ocular Graft Versus Host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Amniotic Fluid Eye Drops (AFED) - All participants, One eye

Group Type ACTIVE_COMPARATOR

Amniotic Fluid Eye Drops (AFED)

Intervention Type BIOLOGICAL

One drop (0.25 mL) in one eye twice daily for up to 3 months

Saline Solution - All participants, One eye

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type OTHER

One drop (0.25 mL) in the other eye twice daily for up to 3 months

Interventions

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Amniotic Fluid Eye Drops (AFED)

One drop (0.25 mL) in one eye twice daily for up to 3 months

Intervention Type BIOLOGICAL

Saline Solution

One drop (0.25 mL) in the other eye twice daily for up to 3 months

Intervention Type OTHER

Eligibility Criteria

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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 at time of accrual after the most recent 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 reason, in the judgement of the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No