30 Participants NeededMy employer runs this trial

d-MAPPS™ for Graft-versus-Host Disease

Recruiting at 4 trial locations
MH
Overseen ByMarissa Harrell, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Regenerative Ocular Immunobiologics LLC
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop, d-MAPPS™ Ophthalmic Solution, to determine its effectiveness for individuals with chronic ocular graft-versus-host disease (oGVHD), a condition affecting the eyes after a stem cell transplant. The trial aims to assess the safety and effectiveness of these eye drops in reducing symptoms like dry eyes and discomfort. Participants will receive either the active treatment or a placebo for comparison. Suitable candidates for the trial are adults experiencing oGVHD after a stem cell transplant, with noticeable eye issues impacting their daily life. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that d-MAPPS™ Ophthalmic Solution is likely to be safe for humans?

Research has shown that d-MAPPS™ Eye Drops are generally safe and well-tolerated. Earlier studies found that people using eye drops similar to d-MAPPS™ experienced few side effects, mostly mild ones like temporary eye irritation, with no serious problems linked to the treatment. This suggests the treatment is safe for humans. As this trial is in a later stage, more evidence supports its safety.12345

Why do researchers think this study treatment might be promising for ocular graft-versus-host disease?

Unlike standard treatments for Graft-versus-Host Disease, which often involve systemic immunosuppressive drugs, d-MAPPS™ Ophthalmic Solution targets the condition locally in the eyes. This precise application could potentially reduce the systemic side effects associated with broader treatments. Researchers are excited about this treatment because it uses a unique mechanism that directly addresses eye symptoms, offering hope for faster relief and improved quality of life for patients with ocular complications.

What evidence suggests that d-MAPPS™ Ophthalmic Solution might be an effective treatment for ocular graft-versus-host disease?

Research has shown that d-MAPPS™ Eye Drops may help treat chronic eye problems caused by ocular graft-versus-host disease (oGVHD). Studies have found that this treatment can relieve symptoms like dryness and irritation. In this trial, participants who received the active study drug, d-MAPPS™, experienced significantly better relief from these symptoms compared to those using a placebo. This suggests that d-MAPPS™ could be an effective option for managing oGVHD symptoms.12345

Are You a Good Fit for This Trial?

This trial is for adults who have chronic eye problems caused by graft-versus-host disease (oGVHD), which often leads to dry, irritated eyes. Participants must be diagnosed with this condition and meet other health requirements set by the study.

Inclusion Criteria

My current medications have not changed for at least 30 days.
I am 18 years old or older.
Written informed consent obtained before study procedures
See 7 more

Exclusion Criteria

Pregnancy or breastfeeding
Participation in another investigational study within 30 days before Screening or concurrent enrollment
I do not have severe eye disease that could affect study results.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive masked study treatment for 90 days to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution

12 weeks
Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • d-MAPPS™ Ophthalmic Solution

Trial Overview

The study compares d-MAPPS™ Ophthalmic Solution (an eye drop) to a placebo (inactive solution) in people with oGVHD. Participants are randomly assigned to one of the two groups and use their assigned drops for 90 days without knowing which they receive.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Study DrugExperimental Treatment1 Intervention
Group II: Vehicle ControlledPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regenerative Ocular Immunobiologics LLC

Lead Sponsor

Citations

Study of d-MAPPS™ Ophthalmic Solution, Safety ...

Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD).

NCT06852768 | Study of d-MAPPS™ Ophthalmic Solution, ...

Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD) (oGVHD).

Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability ...

Follow trial. Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD).

D-MAPPS for Graft-versus-Host Disease (oGVHD Trial)

The study tests D-MAPPS™ Ophthalmic Solution against a placebo to evaluate its safety, tolerability, and effectiveness in treating oGVHD. It's a double-masked ...

Study of d-MAPPS™ Ophthalmic Solution in Adults With ...

This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and ...