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Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)

RecruitingPhase 3

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

Sponsor: Regenerative Ocular Immunobiologics LLC · Participants: 30 · Started: 2026-09

Contact the study team

Official record on ClinicalTrials.gov — NCT07776210

Locations in the U.S.

CaliforniaBeverly Hills Institute of Ophthalmology, Beverly Hills
Beverly Hills Optometry, Beverly Hills
FloridaRegenerative Ocular Immunobiologics, LLC., Palm Harbor (Not yet recruiting)
MassachusettsBostonSight, 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.