d-MAPPS™ for Graft-versus-Host Disease
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive masked study treatment for 90 days to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
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).
3.
ctv.veeva.com
ctv.veeva.com/study/study-of-d-mapps-ophthalmic-solution-safety-tolerability-and-efficacy-in-the-treatment-of-chroniStudy 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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.