NCT07776210PHASE3Recruiting
Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Regenerative Ocular Immunobiologics LLC
Start Date
9/1/2026
Completion Date
6/30/2027
Summary
This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Age 18 years or older.
* Documented chronic ocular graft-versus-host disease (oGVHD) following allogeneic hematopoietic stem cell transplantation.
* Investigator determines the participant is medically stable and appropriate for study participation.
* Ocular Surface Disease Index (OSDI) Total Score of at least 33 at Baseline.
* UNC Dry Eye Management Scale Visual Analog Scale (UNC DEMS VAS) score of at least 3 at Baseline.
* Modified Oxford Corneal Staining Score of at least 1 in at least one eye.
* Snellen Corrected Distance Visual Acuity sufficient to complete protocol-defined assessments.
* Written informed consent obtained before study procedures.
* Willing and able to comply with study visits, study treatment, and protocol requirements.
* Background therapies stable for at least 30 days before Baseline.
Exclusion Criteria:
* Acute ocular graft-versus-host disease or ocular disease that may interfere with efficacy assessment.
* Active ocular or periocular infection, ocular malignancy, or active herpetic keratitis.
* Intraocular surgery, refractive surgery, or ocular laser procedure within 6 weeks before Baseline or planned during the study.
* Change in systemic immunosuppressive therapy, topical glaucoma therapy, or oral tetracycline therapy within 30 days before Baseline.
* Initiation within 30 days before Baseline or during the trial of topical cyclosporine, lifitegrast, tacrolimus, autologous serum eye drops, platelet-rich plasma eye drops, amniotic membrane products, or another prescription therapy intended to treat ocular surface disease.
* Participation in another investigational study within 30 days before Screening or concurrent enrollment.
* Pregnancy or breastfeeding.
Interventions
BIOLOGICAL
d-MAPPS™ Ophthalmic Solution
BIOLOGICAL
Matching vehicle control
Conditions
oGVHDOcular Graft Versus Host Disease
Locations
Beverly Hills Institute of Ophthalmology
Beverly Hills, California 90210
United States
Beverly Hills Optometry
Beverly Hills, California 90211
United States
Regenerative Ocular Immunobiologics, LLC.
Palm Harbor, Florida 34684
United States
Eyewell, LLC.
Boston, Massachusetts 02215
United States
BostonSight
Boston, Massachusetts 02494
United States