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Pancreatic Islet Transplantation to the Anterior Chamber of the Eye (EYELETS)

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.
 
ClinicalTrials.gov Identifier: NCT04198350
Recruitment Status : Suspended (COVID19)
First Posted : December 13, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

This is a phase II prospective, interventional, open-labeled, proof-of-concept study.

2 years per participant, 2 years 6 months in total Total n=6

The primary objective is to assess the safety of human pancreatic islet transplantation into the ACE of participants with T1D.

Safety analyses will involve examination of the incidence, severity, and type of treatment emergent AEs reported, and changes in vital signs, ophthalmic status and laboratory test results from baseline (Day 0 pre-transplantation) to specified time points throughout the study.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Visual Impairment Procedure: Islet implantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This is a phase II prospective, interventional, open-labeled, proof-of-concept study.

2 years per participant, 2 years 6 months in total Total n=6

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pancreatic Islet Transplantation to the Anterior Chamber of the Eye
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Islet implantation Procedure: Islet implantation
Transplantation of allogeneic pancreatic human islets will be performed into the anterior chamber of a single eye with the poorest visual acuity (see inclusion/exclusion criteria below). Up to 40 000 IEQ of islets in a maximum volume of 350µl will be transplanted.




Primary Outcome Measures :
  1. Safety of the procedure with regards to opthalmic complications [ Time Frame: 365 days ]
    Absence of ophthalmic complications (increased IOP, infection, severe inflammation in the treated or fellow eye, evidence of progression of diabetic retinopathy or anterior segment neovascularization) in the transplanted eye.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T1D participants that fulfill criteria for islet transplantation
  • Systemic immunosuppression
  • At least one eye with VA from HM to 0.1, and fellow eye with equal or better VA
  • Age ≥ 18 years
  • Normal cornea with good visualization of the anterior segment
  • Participant not eligible or with no wish for standard pancreatic islet into the hepatic portal system or pancreas transplantation
  • Participants who have recently been involved in research or who are actively involved in research may be recruited at the discretion of the chief investigator if the active research has no impact on glucose self-management.

Exclusion Criteria:

  • VA below HM or above 0.1
  • Neovascular glaucoma
  • Iris neovascularization
  • Ongoing treatment with intraocular anti-VEGF or steroids (and no injection within 4 weeks) in the study eye and no anticipated need for therapy during study period.
  • Ongoing retinal laser photocoagulation
  • Signs of current infection or inflammation
  • Intraocular surgery within 3 months
  • Previous or planned anterior segment surgery for glaucoma
  • Poor visualization of the anterior chamber

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 ClinicalTrials.gov identifier (NCT number): NCT04198350


Locations
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United Kingdom
Imperial College London, Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Nick Oliver Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04198350    
Other Study ID Numbers: 19SM5165
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Type 1 Diabetes
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases