Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
1 other identifier
interventional
2
1 country
2
Brief Summary
The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing incision in the peripheral cornea. The procedure is projected to take approximately 20-30 minutes. Transplant recipients in this study will receive localized maintenance immunosuppression via topical application of eye-drops.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 diabetes
Started Dec 2019
Longer than P75 for phase_1 diabetes
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedStudy Start
First participant enrolled
December 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 12, 2026
March 1, 2026
7.1 years
July 18, 2016
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Absence of ocular complications
Absence of, corneal decompensation, increased intraocular pressure (IOP), uveitis, cataract formation, retinal detachment, retinal bleeding, retinal vasculopathies, macular edema, optic neuropathy, and endophthalmitis in the transplanted eye
24 months after transplant
Absence of sympathetic ophthalmia
Absence of ophthalmic complications in the non-transplanted eye and assessment of diabetic retinopathy compared to baseline before transplant
24 months after transplant
Confirmation of intraocular islet graft survival
Confirmation of positive c-peptide (\>1 ng/ml) in the aqueous humor of the transplanted eye and assessment of intraocular islet graft integrity by slit-lamp microscopy and OCT imaging
24 months after transplant
Study Arms (1)
Human Pancreatic Islet Transplantation
OTHERIslet transplantation into the anterior chamber of the eye single arm
Interventions
Human pancreatic islet transplantation in the eye anterior chamber of legally blind type 1 or type 2 diabetes patients with and without insulin-dependence
Eligibility Criteria
You may qualify if:
- Patient with at least one eye with extensive loss of vision from hand motion to no light perception.
- Phakic or pseudophakic with a stable intraocular lens in the blind eye.
- Normal cornea with good visualization of the anterior segment.
- Normal anterior segment anatomy including the iris bed.
- Male and female subjects ages 18 to 75 years of age and no history of non-compliance.
- Clinical history compatible with T1D or T2D with or without insulin-dependence at the time of enrollment.
- Stable renal function of native or transplanted kidney if applicable.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
You may not qualify if:
- Poor visualization of the anterior chamber (corneal opacity, corneal edema, Herpes Keratitis).
- Aphakic status (no lens).
- Narrow angle of iris anatomy: Spade Scale IV.
- History of uncontrolled glaucoma or glaucoma that had required surgical intervention (e.g., trabeculectomy or shunting devices).
- Active uncontrolled uveitis.
- Presence of silicone in the anterior segment after complex diabetic retinopathy surgery.
- History of allergy to topical steroids and immune-modulatory drugs including CSA and Tacrolimus.
- HbA1c \>10%.
- Blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg.
- Calculated GFR of ≤40 mL/min/1.73 m2 for patients with kidney transplant or \<80 mL/min/1.73 m2 for those without kidney transplant, using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation1.
- Strict vegetarians (vegans) will be excluded only if their estimated GFR is ≤35 mL/min/1.73 m2 for patients with kidney transplant or \<70 mL/min/1.73 m2 for those without kidney transplant.
- Proteinuria (albumin/creatinine ratio or ACr \>300mg/dl) of new onset or since kidney transplantation if applicable.
- Calculated panel-reactive anti-HLA antibodies \>20%.
- Positive crossmatch.
- Antibodies (i.e., presumed de-novo) to the kidney transplant donor, if applicable.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Midhat H. Abdulredalead
- Diabetes Research Institute Foundationcollaborator
- Bascom Palmer Eye Institutecollaborator
Study Sites (2)
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Related Publications (4)
Perez VL, Caicedo A, Berman DM, Arrieta E, Abdulreda MH, Rodriguez-Diaz R, Pileggi A, Hernandez E, Dubovy SR, Parel JM, Ricordi C, Kenyon NM, Kenyon NS, Berggren PO. The anterior chamber of the eye as a clinical transplantation site for the treatment of diabetes: a study in a baboon model of diabetes. Diabetologia. 2011 May;54(5):1121-6. doi: 10.1007/s00125-011-2091-y. Epub 2011 Mar 1.
PMID: 21360190BACKGROUNDShishido A, Caicedo A, Rodriguez-Diaz R, Pileggi A, Berggren PO, Abdulreda MH. Clinical intraocular islet transplantation is not a number issue. CellR4 Repair Replace Regen Reprogram. 2016;4(4):e2120. Epub 2016 Jul 26.
PMID: 29497631BACKGROUNDTun SBB, Chua M, Hasan R, Kohler M, Zheng X, Ali Y, Abdulreda MH, Juntti-Berggren L, Barathi VA, Berggren PO. Islet Transplantation to the Anterior Chamber of the Eye-A Future Treatment Option for Insulin-Deficient Type-2 Diabetics? A Case Report from a Nonhuman Type-2 Diabetic Primate. Cell Transplant. 2020 Jan-Dec;29:963689720913256. doi: 10.1177/0963689720913256.
PMID: 32264703BACKGROUNDAbdulreda MH, Berman DM, Shishido A, Martin C, Hossameldin M, Tschiggfrie A, Hernandez LF, Hernandez A, Ricordi C, Parel JM, Jankowska-Gan E, Burlingham WJ, Arrieta-Quintero EA, Perez VL, Kenyon NS, Berggren PO. Operational immune tolerance towards transplanted allogeneic pancreatic islets in mice and a non-human primate. Diabetologia. 2019 May;62(5):811-821. doi: 10.1007/s00125-019-4814-4. Epub 2019 Jan 31.
PMID: 30701283BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Midhat H Abdulreda, Ph.D.
University of Miami
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Diabetes Research Institute
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 27, 2016
Study Start
December 5, 2019
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share