Pancreatic Islet Transplantation into the Eye for Diabetes
This study is exploring a new way to treat diabetes by transplanting human pancreatic islets (cells that produce insulin) into the front part of the eye. This procedure, called intraocular islet transplantation, involves infusing these cells into the eye through a small incision. The procedure is expected to take about 20-30 minutes. After the transplant, participants will use eye drops to prevent their body from rejecting the new cells. This study is for people aged 18 to 75 with type 1 or type 2 diabetes who are legally blind in at least one eye. Researchers will be looking to see if there are no eye complications, no specific eye inflammation (sympathetic ophthalmia), and if the transplanted cells survive in the eye for 24 months after the procedure. The study is currently unclear on its recruitment status and plans to enroll 2 participants.
- Study design
- This is an interventional study with a planned enrollment of 2 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will undergo a single procedure to transplant cells into their eye, which takes about 20-30 minutes. They will also use eye drops for maintenance immunosuppression.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months after the transplant to check for eye complications and cell survival.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Midhat H Abdulreda, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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What this trial measures
- Absence of ocular complications24 months after transplant
Absence of, corneal decompensation, increased intraocular pressure (IOP), uveitis, cataract formation, retinal detachment, retinal bleeding, retinal vasculopathies, macular edema, optic neuropathy, and endophthalmitis in the transplanted eye
- Absence of sympathetic ophthalmia24 months after transplant
Absence of ophthalmic complications in the non-transplanted eye and assessment of diabetic retinopathy compared to baseline before transplant
- Confirmation of intraocular islet graft survival24 months after transplant
Confirmation of positive c-peptide (\>1 ng/ml) in the aqueous humor of the transplanted eye and assessment of intraocular islet graft integrity by slit-lamp microscopy and OCT imaging