Clinical trial NCT06852768: Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Official title: 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 (oGVHD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: oGHVD
Lead sponsor: Regenerative Ocular Immunobiologics LLC
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

* Age ≥ 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 grad of ≥ 1 in at least one eye.
* OSDI scored of ≥ 22.
* UNC DEMS score of ≥ 3.
* In good stable overall health.

Exclusion Criteria:

* History of Rheumatoid Arthritis, Lupus, Scleroderma.
* 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.

Primary outcomes:
measure: Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores
timeFrame: Through study completion, an average of 4 months.
measure: Changes from Baseline utilizing Ocular Surface Disease Index (OSDI)
timeFrame: Through study completion, an average of 4 months.
Secondary outcomes:
measure: Changes from baseline utilizing the NIH Eye Score for chronic oGVHD
timeFrame: Through study completion, an average of 4 months.
measure: Changes from Baseline Oxford Schema for Corneal and Conjunctival Stain Grades
timeFrame: Through study completion, an average of 4 months.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Beverly Hills Institute of Ophthalmology
state: California
city: Huntington Beach
country: United States
facility: Beach Eye Medical Group
state: California
city: Palm Harbor
country: United States
facility: Regenerative Ocular Immunobiologics, LLC.
state: Florida
city: Lexington
country: United States
facility: Kentucky Eye Institute
state: Kentucky
city: Boston
country: United States
facility: Eyewell, LLC.
state: Massachusetts
Study officials:
References: