BridgeMD
New treatment option for Diabetes
Official title Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
ClinicalTrials.gov ID: NCT02846571
What this study is testing
What is Human Pancreatic Islet Transplantation?
Human Pancreatic Islet Transplantation is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients who meet all of the following criteria are eligible for participation in the study: Ophthalmic
- 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. General and metabolic
You likely can't join if
- Patients who meet any of these criteria are not eligible for participation in the study: Ophthalmic exclusion criteria (only in surgical eye):
- 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.
See the full eligibility criteria
- Patients who meet all of the following criteria are eligible for participation in the study: Ophthalmic
- 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. General and metabolic
- Male and female people 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.
- Patients who meet any of these criteria are not eligible for participation in the study: Ophthalmic exclusion criteria (only in surgical eye):
- 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. General and metabolic exclusion criteria:
- 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...
- 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.
- For female people: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male people: intent to...
- Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). people with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active...
- Negative screen for Epstein-Barr Virus (EBV) by IgG determination.
- Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within one year prior to study enrollment.
- Active malignancy (cancer) except if successfully treated and declared cancer-free and/or in-remission by the oncologist.
- Known active alcohol or substance abuse.
- Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (\<1,000/µL), neutropenia (\<1,500/µL), or thrombocytopenia (platelets \<100,000/µL). Participants with lymphopenia are allowed if the...
- Severe co-existing cardiac disease, characterized by any one of these conditions:
- Recent myocardial infarction (within past 6 months).
- Evidence of ischemia on functional cardiac exam within the last year.
- Left ventricular ejection fraction \<30%.
- Hyperlipidemia despite medical therapy (fasting low-density lipoprotein [LDL] cholesterol \>130 mg/dL, treated or untreated; and/or fasting triglycerides \>200 mg/dL) for patients with kidney transplant.
- Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of ≤5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only.
- Use of any investigational agents within 4 weeks of enrollment.
- Administration of live attenuated vaccine(s) within 2 months of enrollment.
- Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.