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

Purpose

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.

Conditions

  • oGVHD
  • Ocular Graft Versus Host Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Vehicle Controlled
  • Biological: Matching vehicle control
    Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.
Experimental
Active Study Drug
  • Biological: d-MAPPS™ Ophthalmic Solution
    Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.

Recruiting Locations

Beverly Hills Institute of Ophthalmology
Beverly Hills, California 90210
Contact:
Jillian Chong, MD
310-273-2333
drchong@90210eyes.com

Eyewell, LLC.
Boston, Massachusetts 02215
Contact:
Kristen Brown, OD
(617) 433-9895
kristen.brown@myeyewell.com

BostonSight
Boston, Massachusetts 02494
Contact:
Daniel C. Brocks, MD
781-726-7337
DBrocks@bostonsight.org

More Details

Status
Recruiting
Sponsor
Regenerative Ocular Immunobiologics LLC

Study Contact

Marissa Harrell, PhD
727-748-0420
info@roiglobalsolutions.org