d-MAPPS Ophthalmic Solution for Chronic Ocular Graft-Versus-Host Disease
Data Collection
Recruiting
Available upon a request by a licensed MDSummary
Regenerative Ocular Immunobiologics is exploring a new treatment called d-MAPPS™ Ophthalmic Solution for individuals suffering from chronic ocular Graft-Versus-Host Disease (oGVHD), a serious eye condition often with limited treatment options. This investigational treatment is currently being tested in clinical trials to assess its safety and effectiveness. However, some patients who cannot participate in these trials due to specific criteria might still access this treatment through an Expanded Access Policy. This policy is designed to provide the treatment to those with urgent medical needs when no other satisfactory options are available. The aim is to offer hope and potential relief to patients who have not found success with existing treatments. For those eligible for this Expanded Access, the process involves the patient's eye care professional submitting a request detailing the patient's condition and need for the treatment. The request is evaluated based on several criteria, including the severity of the condition and the lack of other treatment options. The company reviews each case carefully and responds promptly to ensure timely access. Importantly, the treatment is currently provided at no cost to the patient, though this policy might change if circumstances require. This approach ensures that the investigational treatment reaches those who need it most, while still following regulatory guidelines.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Criteria
Inclusion Criteria: * Age ≥18 years. * Willing and able to provide written informed consent. * Willing and able to comply with study assessments for the full duration of the study. * Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual. * Minimum Oxford Schema grade of ≥1 in at least one eye. * OSDI score of ≥22. * UNC DEMS score of ≥3. * In good stable overall health * Note: If the patient has no exclusion criteria, investigator can combine the Pre-screen and Baseline visit Exclusion Criteria: * History of Rheumatoid Arthritis, Lupus, Scleroderma. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution). * Ocular or periocular malignancy. * Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry. * Any history of topical tacrolimus use (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution). * Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month. * Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry. * Current use of topical steroids more than twice a day. * Corneal epithelial defect \>1mm2. * Any history of herpetic keratitis. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution). * Participation in another simultaneous medical research study. * Signs of current infection, including fever and current treatment with antibiotics. * All vaccinations including COVID are prohibited during this study. * Intra-ocular surgery or ocular laser surgery within 3 months. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution following surgery.) * Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.) * Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.