NCT02846571 · Midhat H. Abdulreda
Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
What this study is about
The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing incision in the peripheral cornea. The procedure is projected to take approximately 20-30 minutes.
View original scientific description
The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing incision in the peripheral cornea. The procedure is projected to take approximately 20-30 minutes. Subject will remain flat on their back for 1 - 3 hours after islet infusion to maximize adhesion of the islets to the iris.
Interventions
BIOLOGICAL
Human Pancreatic Islet Transplantation
Human pancreatic islet transplantation in the eye anterior chamber of legally blind type 1 or type 2 diabetes patients with and without insulin-dependence
Primary outcome measures
Absence of ocular complications
Time frame: 24 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 ophthalmia
Time frame: 24 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 survival
Time frame: 24 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient with at least one eye with extensive loss of vision from hand motion to no light perception. 2. Phakic or pseudophakic with a stable intraocular lens in the blind eye. 3. Normal cornea with good visualization of the anterior segment. 4. Normal anterior segment anatomy including the iris bed. General and metabolic inclusion criteria: 1. Male and female subjects ages 18 to 75 years of age and no history of non-compliance. 2. Clinical history compatible with T1D or T2D with insulin-dependence at the time of enrollment. 3. Stable renal function of native or transplanted kidney if applicable. 4. Ability to provide written informed consent. 5. Mentally stable and able to comply with the procedures of the study protocol.
Exclusion criteria
- Patients who meet any of these criteria are not eligible for participation in the study: Ophthalmic exclusion crite
Where
- Miami, Florida
Collaborators
Diabetes Research Institute Foundation, Bascom Palmer Eye Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations