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

Part of paid clinical trials in Palm Harbor, Florida.

Sponsor
Regenerative Ocular Immunobiologics LLC
Study ID
NCT07776210
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Ocular Graft Versus Host Disease
  • oGVHD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • d-MAPPS™ Ophthalmic Solution — BIOLOGICAL
    Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.
  • Matching vehicle control — BIOLOGICAL
    Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Aug 19, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Vehicle Controlled
  • Experimental: Active Study Drug

Primary Outcome Measure

Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score [ Time Frame: Baseline to Day 90 (±5 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Regenerative Ocular Immunobiologics, LLC.Palm HarborFlorida34684
Marissa Harrell, CEO, PhD
[email protected]
727-748-0420
Craig Hull, COO
[email protected]
727-460-4116

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By research site
Regenerative Ocular Immunobiologics, LLC.· Palm Harbor, FL

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