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

NCT00853424 | Withdrawn Phase 3

• 1 other identifier: H08-02859
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Keywords

diabetic retinopathy; diabetic macular edema; type 1 diabetes; intensive medical therapy; islet cell transplantation; visual acuity; diabetic eye disease

Outcome Measures

Primary Outcomes (1)

• Composite outcome consisting of progression of DR, development of significant ME, or moderate visual loss in patients who have significant ME at randomization.

Study Arms (2)

M

ACTIVE COMPARATOR

subjects receive all recommended medical treatment for diabetes and diabetic eye disease

Other: Medical therapy

I

EXPERIMENTAL

subjects receive an islet cell transplant in addition to all recommended medical treatment for diabetes and diabetic eye disease

Procedure: islet cell transplant

Interventions

islet cell transplant PROCEDURE

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).

I

Medical therapy OTHER

subjects receive all recommended medical treatment for diabetes and diabetic eye disease

M

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of British Columbia: lead

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 1

Interventions

Islets of Langerhans Transplantation; Nutrition Therapy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Endocrine Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• David M. Thompson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 17, 2014

Record last verified: 2011-11