Actively Recruiting
Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Led by Regenerative Ocular Immunobiologics LLC · Updated on 2026-04-17
1
Participants Needed
6
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of d-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGHVD)
CONDITIONS
Official Title
Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with study assessments for the full duration of the study.
- Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
- Minimum Oxford Schema grade of 65 1 in at least one eye.
- OSDI score of 65 22.
- UNC DEMS score of 65 3.
- In good stable overall health.
You will not qualify if you...
- History of Rheumatoid Arthritis, Lupus, Scleroderma.
- Ocular or periocular malignancy.
- Significant change in systemic immunosuppressive regimen within 2 weeks of study entry.
- Any history of topical tacrolimus use.
- Any change in dosage of tetracycline compounds within the last month.
- Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
- Current use of topical steroids more than twice a day.
- Corneal epithelial defect larger than 1mm2.
- Any history of herpetic keratitis.
- Participation in another simultaneous medical research study.
- Signs of current infection, including fever and current treatment with antibiotics.
- All vaccinations including COVID are prohibited during this study.
- Intra-ocular surgery or ocular laser surgery within 3 months.
- Women who are pregnant, breastfeeding, or plan to become pregnant during study participation.
- Unwillingness to use effective birth control if of childbearing potential.
- Any condition preventing compliance with study requirements including language barrier.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, United States, 90210
Actively Recruiting
2
Beach Eye Medical Group
Huntington Beach, California, United States, 92648
Actively Recruiting
3
Regenerative Ocular Immunobiologics, LLC.
Palm Harbor, Florida, United States, 34684
Actively Recruiting
4
Glenn Eye Center
Lexington, Kentucky, United States, 40511
Actively Recruiting
5
Eyewell, LLC.
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
BostonSight
Boston, Massachusetts, United States, 02494
Actively Recruiting
Research Team
M
Marissa Harrell, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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