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

Regenerative Ocular Immunobiologics LLC

Status and phase

Enrolling

Phase 3

Conditions

oGVHD

Ocular Graft Versus Host Disease

Treatments

Biological: d-MAPPS™ Ophthalmic Solution

Biological: Matching vehicle control

Study type

Interventional

Funder types

Industry

Identifiers

NCT07776210

IND 30066-PIVOT

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.