Phase 2
N=30
Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)
Ocular Graft Versus Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT03298815 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Overall Response Rate — 3; 6 eyes — p=0.375
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Amniotic Fluid Eye Drops (AFED) (Biological); Saline Solution (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
3; 6 | 0.375 |
| SECONDARY Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 30 Days |
-1 | 0.391 |
| SECONDARY Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 60 Days |
2.8 | 0.267 |
| SECONDARY Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 100 Days |
3.0 | 0.445 |
| SECONDARY Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 30 Days |
3; 0; 10 | 0.250 |
| SECONDARY Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 60 Days |
1; 0; 14 | <1.00 |
| SECONDARY Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 100 Days |
2; 0; 13 | 0.500 |
| SECONDARY Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline to 30 Days |
3; 5; 5 | 0.563 |
| SECONDARY Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 60 Days |
0; 8; 6 | 0.008 sig |
| SECONDARY Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 100 Days |
1; 5; 7 | 0.156 |
| SECONDARY Change in Pain Assessment From Baseline to 60 Days |
-0.004; -0.010 | 0.208 |
| SECONDARY Changes in Visual Acuity |
5; 2; 6; 2; 5; 7 | 0.594 |
| SECONDARY Effects on the Corneal Surface |
1; 7; 5; 3; 4; 7 | 0.063 |
Summary
A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.
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 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.
Data sourced from ClinicalTrials.gov (NCT03298815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.