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

This study is currently recruiting participants.
Verified November 2011 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00853424
First received: February 26, 2009
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Diabetic Retinopathy
Diabetic Macular Edema
 Procedure: islet cell transplant
Other: Medical therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Composite outcome consisting of progression of DR, development of significant ME, or moderate visual loss in patients who have significant ME at randomization. [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853424

Contacts
Contact: Sharon Kozak 604-875-5997 sekozak@vch.ca

Locations
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Sharon Kozak     604-875-5997     sekozak@vch.ca    
Principal Investigator: David M. Thompson, MD            
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: David M. Thompson, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00853424     History of Changes
Other Study ID Numbers: H08-02859
Study First Received: February 26, 2009
Last Updated: November 21, 2011
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 21, 2013