Pancreatic Islet Transplantation to the Anterior Chamber of the Eye (NCT04198350) | Clinical Trial Compass
WithdrawnNot Applicable
Pancreatic Islet Transplantation to the Anterior Chamber of the Eye
Stopped: Unable to recruit
United Kingdom0Started 2022-09-01
Plain-language summary
This is a phase II prospective, interventional, open-labeled, proof-of-concept study.
2 years per participant, 2 years 6 months in total Total n=6
The primary objective is to assess the safety of human pancreatic islet transplantation into the ACE of participants with T1D.
Safety analyses will involve examination of the incidence, severity, and type of treatment emergent AEs reported, and changes in vital signs, ophthalmic status and laboratory test results from baseline (Day 0 pre-transplantation) to specified time points throughout the study.
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:
* T1D participants that fulfill criteria for islet transplantation
* Systemic immunosuppression
* At least one eye with VA from HM to 0.1, and fellow eye with equal or better VA
* Age ≥ 18 years
* Normal cornea with good visualization of the anterior segment
* Participant not eligible or with no wish for standard pancreatic islet into the hepatic portal system or pancreas transplantation
* Participants who have recently been involved in research or who are actively involved in research may be recruited at the discretion of the chief investigator if the active research has no impact on glucose self-management.
Exclusion Criteria:
* VA below HM or above 0.1
* Neovascular glaucoma
* Iris neovascularization
* Ongoing treatment with intraocular anti-VEGF or steroids (and no injection within 4 weeks) in the study eye and no anticipated need for therapy during study period.
* Ongoing retinal laser photocoagulation
* Signs of current infection or inflammation
* Intraocular surgery within 3 months
* Previous or planned anterior segment surgery for glaucoma
* Poor visualization of the anterior chamber
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.
What they're measuring
1
Safety of the procedure with regards to opthalmic complications