Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

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.

Conditions

Diabetes

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Study Details

Study overview

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.

Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

Condition
Diabetes
Intervention / Treatment

-

Contacts and Locations

Miami

Bascom Palmer Eye Institute, Miami, Florida, United States, 33136

Miami

Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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.
  • 1. Poor visualization of the anterior chamber (corneal opacity, corneal edema, Herpes Keratitis).
  • 2. Aphakic status (no lens).
  • 3. Narrow angle of iris anatomy: Spade Scale IV.
  • 4. History of uncontrolled glaucoma or glaucoma that had required surgical intervention (e.g., trabeculectomy or shunting devices).
  • 5. Active uncontrolled uveitis.
  • 6. Presence of silicone in the anterior segment after complex diabetic retinopathy surgery.
  • 7. History of allergy to topical steroids and immune-modulatory drugs including CSA and Tacrolimus.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Midhat H. Abdulreda,

Midhat Abdulreda, Ph.D., PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2027-12-31