Status:
WITHDRAWN
A Comparison of Islet Cell Transplantation With Medical Therapy for the Treatment of Diabetic Eye Disease
Lead Sponsor:
University of British Columbia
Conditions:
Diabetic Retinopathy
Diabetic Macular Edema
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
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 ...
Detailed Description
Study Purpose The purpose of the study is to determine if islet cell transplantation (ICT) is more effective than intensive medical therapy at reducing the progression of diabetic retinopathy. Hypot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00853424
Start Date
December 1 2009
End Date
December 1 2010
Last Update
March 17 2014
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