Recruiting
Phase 3

d-MAPPS™

Sponsor:

Regenerative Ocular Immunobiologics LLC

Code:

NCT07776210

Conditions

oGVHD

Ocular Graft Versus Host Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

d-MAPPS™ Ophthalmic Solution

Matching vehicle control

Study Details

Brief summary:

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

Study ID

NCT07776210

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Vehicle Controlled

experimental: Active Study Drug

Interventions

d-MAPPS™ Ophthalmic Solution

Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.

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.

Primary outcome measure

  • Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score [ Time Frame: Baseline to Day 90 (±5 days) ]
  • Change From Baseline to Day 90 in Ocular Surface Disease Index (OSDI) Total Score [ Time Frame: Baseline to Day 90 (±5 days) ]

Central Contacts and Locations

Central contacts

Marissa Harrell, PhD

727-748-0420info@roiglobalsolutions.org

Locations

Beverly Hills Institute of Ophthalmology

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Jillian Chong, MD

310-273-2333drchong@90210eyes.com

Principal Investigator:

Jillian Chong, MD

Beverly Hills Optometry

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Kambiz Silani, OD

310-659-2020

bheyeguy@gmail.com

Principal Investigator:

Kambiz Silani, OD

Eyewell, LLC.

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Kristen Brown, OD

(617) 433-9895kristen.brown@myeyewell.com

Principal Investigator:

Kristen Brown, OD

BostonSight

Recruiting

Boston, Massachusetts, United States, 02494

Contacts

Daniel C. Brocks, MD

781-726-7337DBrocks@bostonsight.org

Principal Investigator:

Daniel C. Brocks, MD

More Information

Sponsor

Regenerative Ocular Immunobiologics LLC

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • oGVHD
  • Ocular Graft-Versus-Host Disease
  • Ocular Graft Versus Host Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regenerative Ocular Immunobiologics LLC on 2026-09-04.