Pancreatic Islet Transplantation to the Anterior Chamber of the Eye

NCT04198350 | Withdrawn DMC

• 1 other identifier: 19SM5165
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Visual Impairment

Keywords

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Safety of the procedure with regards to opthalmic complications

  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.

  365 days

Study Arms (1)

Islet implantation

EXPERIMENTAL

Procedure: Islet implantation

Interventions

Islet implantation PROCEDURE

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.

Islet implantation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London, Imperial College Healthcare NHS Trust

London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Vision Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nick Oliver

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: September 1, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)