Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 8 April 2024
• Main ID: NCT02916680
• Date of registration: 31/03/2016
• Prospective Registration: No
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
• Scientific title: Pancreatic Islet Transplantation in the Anterior Chamber of the Human Eye - a Pilot Study
• Date of first enrolment: March 2016
• Target sample size: 4
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02916680
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Marc Y Donath, Prof.

• Name: Marc Y Donath, Prof.

• Name: Marc Y Donath, Prof.
• Affiliation: University Hospital, Basel, Switzerland

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Type 1 Diabetes (American Diabetes Association criteria)

2. Kidney transplant recipient with ongoing immunosuppression

3. At least one eye with extensive loss of vision from hand motion to no light perception
due to damage of retina or optic nerve

4. Age = 18 years

5. Normal cornea with good visualization of the anterior segment

6. Patient not eligible or with no wish for standard pancreatic islet into the hepatic
portal system or pancreas transplantation

Exclusion Criteria:

1. Uncontrolled diabetic retinopathy

2. Signs of current infection

3. Poor visualization of the anterior chamber



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

Procedure: Pancreatic islet transplantation in the anterior chamber

Primary Outcome(s)

Absence of ophthalmic complications [Time Frame: 90 days]

Secondary Outcome(s)

Change in total number of hypoglycemic events [Time Frame: 90 days]

Change in insulin production [Time Frame: 90 days]

Change in fasting glucose [Time Frame: 90 days]

Change in HbA1c [Time Frame: 90 days]

Change in insulin requirements [Time Frame: 90 days]

Secondary ID(s)

Eye ITPL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors