Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus… (NCT07210619) | Clinical Trial Compass
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Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Plain-language summary
Regenerative Ocular Immunobiologics, LLC Fast Track Expanded Access This Expanded Access Policy describes the conditions under which ROI may make its investigational product - Sterile Processed Derived Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS™ Ophthalmic Solution) - available to patients outside of a clinical trial, in accordance with U.S. FDA regulations, including section 561A of the Federal Food, Drug, and Cosmetic Act (FDCA).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.