Home › NCT07776210
Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
A Randomized, Double-Masked, Vehicle-Controlled, Adequate and Well-Controlled Pivotal Study With Co-Primary Endpoints to Evaluate the Safety and Efficacy of d-MAPPS™ Ophthalmic Solution in Subjects With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- d-MAPPS™ Ophthalmic Solution (biological)
- Matching vehicle control (biological)
Sponsor: Regenerative Ocular Immunobiologics LLC · Participants: 30 · Started: 2026-09
Contact the study team
- Marissa Harrell, PhD · Phone: 727-748-0420
Official record on ClinicalTrials.gov — NCT07776210
Locations in the U.S.
| California | Beverly Hills Institute of Ophthalmology, Beverly Hills Beverly Hills Optometry, Beverly Hills |
| Florida | Regenerative Ocular Immunobiologics, LLC., Palm Harbor (Not yet recruiting) |
| Massachusetts | BostonSight, Boston Eyewell, LLC., Boston |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.