A Comparison of Islet Cell Transplantation With Medical Therapy for the Treatment of Diabetic Eye Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00853424
Recruitment Status : Withdrawn ("We were unable to enroll any subjects in this study due to lack of interest.")
First Posted : March 2, 2009
Last Update Posted : March 17, 2014
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
Diabetic eye disease remains a major cause of visual loss for individuals with type 1 diabetes, despite currently available treatments. Preliminary studies indicate that islet cell transplantation, a new treatment for type 1 diabetes, may be beneficial for some people. This study is designed to test the hypothesis that islet cell transplantation is more effective than current medical therapy in preventing the progression of diabetic eye disease.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Diabetic Macular Edema Procedure: islet cell transplant Other: Medical therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Islet Cell Transplantation With Medical Therapy on the Risk of Progression of Diabetic Retinopathy and Diabetic Macular Edema
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: M
subjects receive all recommended medical treatment for diabetes and diabetic eye disease
Other: Medical therapy
subjects receive all recommended medical treatment for diabetes and diabetic eye disease

Experimental: I
subjects receive an islet cell transplant in addition to all recommended medical treatment for diabetes and diabetic eye disease
Procedure: islet cell transplant
Human pancreases are retrieved from multiorgan donors and processed with intraductal collagenase perfusion, continuous digestion, and density gradient purification with impure tissue fractions cultured in vitro and then repurified to retrieve additional islets. Islets are implanted by ultrasound guided percutaneous portal embolization, to provide more than 12, 000 islet equivalents (IE) per kilogram of body weight (infusions from 1-3 donors per patient) Immunosuppression consists of antithymocyte globulin, basiliximab, mycophenolate mofetil and tacrolimus as described (Warnock et al Arch Surg 2005;140:735).

Primary Outcome Measures :
  1. Composite outcome consisting of progression of DR, development of significant ME, or moderate visual loss in patients who have significant ME at randomization.

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject level Criteria
  • similar to those used in our initial study (Warnock 2005)
  • age 20 - 60 years
  • type 1 diabetes for > 5 years with negative C peptide
  • GFR > 70 ml/min
  • Panel reactive antibody titre ≤ 15%
  • Non-smoker for ≥ 1 year
  • Body mass index (BMI) ≤ 28
  • Ability to provide informed consent
  • Eye criteria (must be present in both eyes)
  • Presence of moderate to severe nonproliferative diabetic retinopathy (NPDR) (grades 43 - 53 inclusive) in each eye with no plan for panretinal photocoagulation (PRP) earlier than recommended by guidelines
  • Best corrected VA 20/40 (70 letters) or better in each eye
  • Media clarity sufficient to obtain fundus photographs and optical coherence tomography (OCT)

Exclusion Criteria:

  • Subject level criteria
  • Previous organ transplant
  • History of malignancy other than non-melanoma skin cancer
  • Active heart disease
  • Planned pregnancy
  • Active infection
  • Lack of compliance to follow the requirements of intensive medical management of diabetes and immunosuppression protocols
  • Eye level criteria
  • History of PRP. Prior focal/grid photocoagulation more than 6 months previously for clinically significant macular edema (CSME) is not an exclusion criteria or previous limited local laser treatment
  • Macular edema from a cause other than diabetes
  • An ocular condition other than diabetes that, in the opinion of the investigator, might affect the progression of DR, ME or alter VA during the course of the study
  • History of major ocular surgery with the previous 6 months or anticipated within 3 years of randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00853424

Sponsors and Collaborators
University of British Columbia
Principal Investigator: David M. Thompson, MD University of British Columbia

Responsible Party: University of British Columbia Identifier: NCT00853424     History of Changes
Other Study ID Numbers: H08-02859
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: November 2011

Keywords provided by University of British Columbia:
diabetic retinopathy
diabetic macular edema
type 1 diabetes
intensive medical therapy
islet cell transplantation
visual acuity
diabetic eye disease

Additional relevant MeSH terms:
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases