Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03298815
Recruitment Status : Not yet recruiting
First Posted : October 2, 2017
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
John Phillips, University of Utah

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.

Condition or disease Intervention/treatment Phase
Ocular Graft Versus Host Disease Biological: Amniotic Fluid Eye Drops (AFED) Other: Saline Solution Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024


Arm Intervention/treatment
Active Comparator: Amniotic Fluid Eye Drops (AFED) - All participants, One eye Biological: Amniotic Fluid Eye Drops (AFED)
One drop (0.25 mL) in one eye twice daily for up to 3 months

Placebo Comparator: Saline Solution - All participants, One eye Other: Saline Solution
One drop (0.25 mL) in the other eye twice daily for up to 3 months




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 100 days ]
    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.

  2. Safety of pAF in patients with chronic ocular GVHD: CTCAE version 4 [ Time Frame: 100 days ]
    Serious adverse events and ocular adverse events using CTCAE version 4


Secondary Outcome Measures :
  1. Functional Assessment of Cancer Therapy: General (FACT-G) [ Time Frame: 30 days ]
    Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).

  2. Functional Assessment of Cancer Therapy: General (FACT-G) [ Time Frame: 60 days ]
    Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).

  3. Functional Assessment of Cancer Therapy: General (FACT-G) [ Time Frame: 100 days ]
    Change in Quality of Life questionnaire using a five-point scale from 0 (not at all) to 4 (very much).

  4. National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD [ Time Frame: 30 days ]
    Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).

  5. National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD [ Time Frame: 60 days ]
    Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).

  6. National Institutes of Health (NIH) Consensus Criteria (CC) ocular score of chronic GVHD [ Time Frame: 100 days ]
    Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms).

  7. Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading [ Time Frame: 30 days ]
    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.

  8. Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading [ Time Frame: 60 days ]
    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.

  9. Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading [ Time Frame: 100 days ]
    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.

  10. Pain Assessment [ Time Frame: 60 days ]
    Change in patient reported pain level using 0-10 pain rating scale with zero being no pain to 10 being very severe pain.

  11. Changes in Visual Acuity [ Time Frame: Up to 100 days ]
    Ophthalmologic assessment to determine changes in visual acuity related to the administration of pAF.

  12. Effects on the Corneal Surface [ Time Frame: Up to 100 days ]
    Ophthalmologic assessment to determine the effects of treatment with pAF on the corneal surface of patients with ocular chronic GVHD.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed within 3 years after hematopoietic stem cell transplant for any disease, with any graft and any conditioning regimen with at least one of the following:

    1. Dry eye symptoms partially affecting (requiring lubricant drops > 3 x per day or punctal plugs) 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 2 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298815


Contacts
Layout table for location contacts
Contact: John Phillips, PhD 801-581-6650 john.phillips@hsc.utah.edu
Contact: Jan Pierce, MBA 801-585-9539 jan.pierce@hsc.utah.edu

Sponsors and Collaborators
University of Utah
Investigators
Layout table for investigator information
Principal Investigator: John Phillips, PhD University of Utah

Layout table for additonal information
Responsible Party: John Phillips, PhD, University of Utah
ClinicalTrials.gov Identifier: NCT03298815     History of Changes
Other Study ID Numbers: 103515
First Posted: October 2, 2017    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Graft vs Host Disease
Immune System Diseases
Ophthalmic Solutions
Pharmaceutical Solutions