Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegenerative Ocular Immunobiologics LLC
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- d-MAPPS™ Ophthalmic Solution
- Matching vehicle control
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov