RECRUITING

Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye

Quick Facts

Study Start:2019-12-05
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02846571

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient with at least one eye with extensive loss of vision from hand motion to no light perception.
  2. 2. Phakic or pseudophakic with a stable intraocular lens in the blind eye.
  3. 3. Normal cornea with good visualization of the anterior segment.
  4. 4. Normal anterior segment anatomy including the iris bed.
  1. 1. Poor visualization of the anterior chamber (corneal opacity, corneal edema, Herpes Keratitis).
  2. 2. Aphakic status (no lens).
  3. 3. Narrow angle of iris anatomy: Spade Scale IV.
  4. 4. History of uncontrolled glaucoma or glaucoma that had required surgical intervention (e.g., trabeculectomy or shunting devices).
  5. 5. Active uncontrolled uveitis.
  6. 6. Presence of silicone in the anterior segment after complex diabetic retinopathy surgery.
  7. 7. History of allergy to topical steroids and immune-modulatory drugs including CSA and Tacrolimus.

Contacts and Locations

Study Contact

Midhat Abdulreda, Ph.D.
CONTACT
305-243-9871
mabdulreda@miami.edu
Sonia H Yoo, M.D.
CONTACT
305-326-6000
syoo@med.miami.edu

Principal Investigator

Midhat Abdulreda, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Midhat H. Abdulreda

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-05
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2019-12-05
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Islet Transplantation
  • Type 1 Diabetes
  • Immune Tolerance Induction
  • Diabetes Complications
  • Intraocular Transplantation
  • Eye Anterior Chamber
  • Kidney Transplantation
  • Immunosuppression
  • Type 2 Diabetes
  • Eye Drops Immunosuppression
  • localized immunosuppression

Additional Relevant MeSH Terms

  • Diabetes