Actively Recruiting
Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
Led by Midhat H. Abdulreda · Updated on 2026-03-12
2
Participants Needed
2
Research Sites
421 weeks
Total Duration
On this page
Sponsors
M
Midhat H. Abdulreda
Lead Sponsor
D
Diabetes Research Institute Foundation
Collaborating Sponsor
AI-Summary
What this Trial 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. Transplant recipients in this study will receive localized maintenance immunosuppression via topical application of eye-drops.
CONDITIONS
Official Title
Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with at least one eye with extensive loss of vision from hand motion to no light perception
- Phakic or pseudophakic with a stable intraocular lens in the blind eye
- Normal cornea with good visualization of the anterior segment
- Normal anterior segment anatomy including the iris bed
- Male and female subjects ages 18 to 75 years
- Clinical history compatible with type 1 or type 2 diabetes with or without insulin dependence
- Stable renal function of native or transplanted kidney if applicable
- Ability to provide written informed consent
- Mentally stable and able to comply with the study procedures
You will not qualify if you...
- Poor visualization of the anterior chamber due to corneal opacity, edema, or Herpes Keratitis in the surgical eye
- Aphakic status (no lens) in the surgical eye
- Narrow angle iris anatomy (Spade Scale IV) in the surgical eye
- History of uncontrolled glaucoma or glaucoma requiring surgery
- Active uncontrolled uveitis
- Presence of silicone in the anterior segment after complex diabetic retinopathy surgery
- Allergy to topical steroids or immune-modulatory drugs including CSA and Tacrolimus
- HbA1c greater than 10%
- Blood pressure: systolic over 160 mmHg or diastolic over 100 mmHg
- Low kidney function (GFR ≤40 mL/min/1.73 m2 with kidney transplant or <80 mL/min/1.73 m2 without)
- Strict vegetarians with estimated GFR ≤35 mL/min/1.73 m2 with kidney transplant or <70 mL/min/1.73 m2 without
- New or post-transplant proteinuria (albumin/creatinine ratio >300 mg/dl)
- Panel-reactive anti-HLA antibodies greater than 20%
- Positive crossmatch
- Antibodies to kidney transplant donor if applicable
- For females: positive pregnancy test, breastfeeding, or unwilling to use effective contraception during and 4 months after study
- For males: intent to procreate or unwilling to use effective contraception during and 4 months after study
- Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
- Negative Epstein-Barr Virus IgG test
- Recent invasive fungal infections within one year
- Active cancer except if treated and in remission
- Known active alcohol or substance abuse
- Low blood counts or blood abnormalities unless cleared by hematologist
- Severe cardiac disease such as recent heart attack, ischemia, or ejection fraction under 30%
- Hyperlipidemia despite treatment for kidney transplant patients
- Chronic systemic steroid use except low-dose replacement
- Use of investigational agents within 4 weeks
- Live attenuated vaccine within 2 months
- Any medical condition that would interfere with safe participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Actively Recruiting
2
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
M
Midhat H Abdulreda, Ph.D.
CONTACT
S
Sonia Yoo, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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