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Recruiting Phase 1/2 NCT06852768

Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

Phase 1/2 – combined early trial
Conditions: oGHVD

Sponsor: Regenerative Ocular Immunobiologics LLC

trial.available_in: БГ
Overview
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)
Who can participate
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.
Interventions
d-MAPPS
BIOLOGICAL
Placebo
BIOLOGICAL
PI and Patient Masked
OTHER
Locations 6
United States (6)
Beverly Hills Institute of Ophthalmology
Beverly Hills , California
Eyewell, LLC.
Boston , Massachusetts
BostonSight
Boston , Massachusetts
Beach Eye Medical Group
Huntington Beach , California
Samir A Shah, MD, MS, FACS
Glenn Eye Center
Lexington , Kentucky
Regenerative Ocular Immunobiologics, LLC.
Palm Harbor , Florida
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
10.01.2025
Completion date
01.12.2026
Registry ID
NCT06852768
Source
clinicaltrials.gov
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