Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
NCT ID: NCT06852768
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
1 participants
INTERVENTIONAL
2025-01-10
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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This arm randomizes the actual drug to the patient.
Based on randomization, d-MAPPS™ will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
d-MAPPS
Based on randomization d-MAPPS, will be self-administered, 2 drops into each eye four times a day (QID) a day for ninety (90) days.
This arm randomizes the placebo to the patient.
Based on randomization Placebo/sterile water, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Placebo
Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Both patient and PI are masked.
Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.
d-MAPPS
Based on randomization d-MAPPS, will be self-administered, 2 drops into each eye four times a day (QID) a day for ninety (90) days.
Placebo
Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
PI and Patient Masked
Both the PI and the participant are masked on the drug administered.
Interventions
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d-MAPPS
Based on randomization d-MAPPS, will be self-administered, 2 drops into each eye four times a day (QID) a day for ninety (90) days.
Placebo
Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
PI and Patient Masked
Both the PI and the participant are masked on the drug administered.
Eligibility Criteria
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Inclusion Criteria
* 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 grad of ≥ 1 in at least one eye.
* OSDI scored of ≥ 22.
* UNC DEMS score of ≥ 3.
* In good stable overall health.
Exclusion Criteria
* Ocular or periocular malignancy.
* Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
* Any history of topical tacrolimus use.
* Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) 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 \> 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 vaccination including COVID are prohibited during this 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 while participating in the study. If of childbearing potential, unwillingness to use effective birth control while participating in the study.
* Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
18 Years
ALL
No
Sponsors
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Regenerative Ocular Immunobiologics LLC
INDUSTRY
Responsible Party
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Locations
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Beverly Hills Institute of Ophthalmology
Beverly Hills, California, United States
Beach Eye Medical Group
Huntington Beach, California, United States
Regenerative Ocular Immunobiologics, LLC.
Palm Harbor, Florida, United States
Glenn Eye Center
Lexington, Kentucky, United States
Eyewell, LLC.
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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30066
Identifier Type: -
Identifier Source: org_study_id
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