Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye (NCT02846571) | Clinical Trial Compass
RecruitingPhase 1/2
Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
United States2 participantsStarted 2019-12-05
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).