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

Primary Purpose

Ocular Graft Versus Host Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Amniotic Fluid Eye Drops (AFED)
Saline Solution
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Graft Versus Host Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

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

Saline Solution - All participants, One eye

Arm Description

Outcomes

Primary Outcome Measures

Overall Response Rate
Response is a composite of the NIH Consensus Conference (CC) for assessment of response in chronic GVHD (eye score) and the International Dry Eye Workshop (DEWS) grading scale. Responders would be defined as a one point improvement in the dry eye grading scale (DEWS), without worsening in the eye score.
Safety of pAF in patients with chronic ocular GVHD: CTCAE version 4
Serious adverse events and ocular adverse events using CTCAE version 4

Secondary Outcome Measures

Functional Assessment of Cancer Therapy: General (FACT-G)
Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).
Functional Assessment of Cancer Therapy: General (FACT-G)
Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).
Functional Assessment of Cancer Therapy: General (FACT-G)
Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).
National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD
Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).
National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD
Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).
National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD
Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).
Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading
Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.
Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading
Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.
Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading
Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.
Pain Assessment
Change in patient reported pain level using 0-10 pain rating scale with zero being no pain to 10 being very severe pain.
Changes in Visual Acuity
Ophthalmologic assessment to determine changes in visual acuity related to the administration of pAF.
Effects on the Corneal Surface
Ophthalmologic assessment to determine the effects of treatment with pAF on the corneal surface of patients with ocular chronic GVHD.

Full Information

First Posted
September 13, 2017
Last Updated
July 5, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT03298815
Brief Title
Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)
Official Title
A Randomized, Double-Blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
February 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Graft Versus Host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amniotic Fluid Eye Drops (AFED) - All participants, One eye
Arm Type
Active Comparator
Arm Title
Saline Solution - All participants, One eye
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Amniotic Fluid Eye Drops (AFED)
Intervention Description
One drop (0.25 mL) in one eye twice daily for up to 3 months
Intervention Type
Other
Intervention Name(s)
Saline Solution
Intervention Description
One drop (0.25 mL) in the other eye twice daily for up to 3 months
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Response is a composite of the NIH Consensus Conference (CC) for assessment of response in chronic GVHD (eye score) and the International Dry Eye Workshop (DEWS) grading scale. Responders would be defined as a one point improvement in the dry eye grading scale (DEWS), without worsening in the eye score.
Time Frame
100 days
Title
Safety of pAF in patients with chronic ocular GVHD: CTCAE version 4
Description
Serious adverse events and ocular adverse events using CTCAE version 4
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy: General (FACT-G)
Description
Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).
Time Frame
30 days
Title
Functional Assessment of Cancer Therapy: General (FACT-G)
Description
Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).
Time Frame
60 days
Title
Functional Assessment of Cancer Therapy: General (FACT-G)
Description
Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).
Time Frame
100 days
Title
National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD
Description
Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).
Time Frame
30 days
Title
National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD
Description
Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).
Time Frame
60 days
Title
National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD
Description
Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).
Time Frame
100 days
Title
Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading
Description
Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.
Time Frame
30 days
Title
Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading
Description
Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.
Time Frame
60 days
Title
Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading
Description
Ophthalmologic assessment to determine changes in dry eye signs/symptoms each graded on a scale of 1 to 4 with 1 being non/mild to 4 being most severe for a total score.
Time Frame
100 days
Title
Pain Assessment
Description
Change in patient reported pain level using 0-10 pain rating scale with zero being no pain to 10 being very severe pain.
Time Frame
60 days
Title
Changes in Visual Acuity
Description
Ophthalmologic assessment to determine changes in visual acuity related to the administration of pAF.
Time Frame
Up to 100 days
Title
Effects on the Corneal Surface
Description
Ophthalmologic assessment to determine the effects of treatment with pAF on the corneal surface of patients with ocular chronic GVHD.
Time Frame
Up to 100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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) Unable to work because of ocular symptoms 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine J. Lee, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

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

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