Print

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.