Treatment of chronic ocular graft-versus-host disease with d-MAPPS™ solution
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)
PHASE1; PHASE2 · Regenerative Ocular Immunobiologics LLC · NCT06852768
This study is testing a new eye drop solution to see if it can help people with chronic eye problems caused by graft-versus-host disease feel better and improve their eye health.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regenerative Ocular Immunobiologics LLC (industry) |
| Locations | 6 sites (Beverly Hills, California and 5 other locations) |
| Trial ID | NCT06852768 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and efficacy of d-MAPPS™ ophthalmic solution in patients suffering from chronic ocular graft-versus-host disease (oGVHD). It is a double-masked, randomized, placebo-controlled study, meaning neither the participants nor the investigators know who receives the treatment or placebo. The study aims to assess the impact of the treatment on ocular symptoms and overall eye health in eligible participants over a specified duration.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of chronic ocular graft-versus-host disease and specific ocular symptom scores.
Not a fit: Patients with a history of certain autoimmune diseases or significant ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic ocular graft-versus-host disease.
How similar studies have performed: While this approach is novel, similar studies targeting ocular conditions have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beverly Hills, California and 5 other locations
- Beverly Hills Institute of Ophthalmology — Beverly Hills, California, United States (RECRUITING)
- Beach Eye Medical Group — Huntington Beach, California, United States (RECRUITING)
- Regenerative Ocular Immunobiologics, LLC. — Palm Harbor, Florida, United States (RECRUITING)
- Glenn Eye Center — Lexington, Kentucky, United States (RECRUITING)
- Eyewell, LLC. — Boston, Massachusetts, United States (RECRUITING)
- BostonSight — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Marissa Harrell, Phd
- Email: info@roiglobalsolutions.org
- Phone: 727-748-0420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: oGHVD