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

Not Yet RecruitingPhase 3

Sponsor: Regenerative Ocular Immunobiologics LLC

Conditions: oGVHD, Ocular Graft Versus Host Disease

Interventions: d-MAPPS™ Ophthalmic Solution, Matching vehicle control

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Palm Harbor, Florida, United States