Phase 2 Type 1 Diabetes Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Eye-related criteria (for the eye being treated):

• People who have at least one eye with very severe vision loss, ranging from only being able to see a hand waving in front of them down to no light perception at all.
• People whose eye being treated still has its natural lens, or has a stable artificial lens from previous cataract surgery.
• People whose cornea (the clear front surface of the eye) is clear and allows a good view into the eye.
• People whose eye has normal internal front-of-eye structures, including the iris (the coloured part of the eye).

General and health-related criteria:

• People between 18 and 75 years of age, with no history of not following medical instructions.
• People with a clinical history consistent with Type 1 or Type 2 diabetes, whether or not insulin is used.
• People whose kidney function — whether their own kidney or a transplanted one — is stable at the time of joining.
• People who are able to read and sign a written consent form.
• People who are mentally stable and able to follow the steps of the study as required.

Who may not be able to join:

Eye-related criteria (for the eye being treated):

• People whose cornea is cloudy, swollen, or affected by a herpes eye infection that prevents a clear view inside the eye.
• People whose eye has no lens at all (neither natural nor artificial).
• People whose eye has a very narrow iris angle (classified as Spade Scale IV) (confirm with trial site).
• People with a history of glaucoma that was uncontrolled or required surgery such as a trabeculectomy or drainage device.
• People with currently active and uncontrolled inflammation inside the eye (uveitis).
• People who have silicone material remaining in the front part of the eye following previous complex diabetic eye surgery.
• People with a known allergy to steroid eye drops or immune-suppressing medications including cyclosporine (CSA) or tacrolimus.

General and health-related criteria:

• People whose HbA1c blood sugar control measure is above 10% (confirm with trial site).
• People whose blood pressure is above 160/100 mmHg.
• People whose kidney filtering function (measured by a calculation called eGFR) falls below certain levels — the specific cut-off depends on whether the person has a transplanted kidney or not (confirm with trial site).
• Strict vegans whose kidney filtering function falls below certain levels — again depending on whether they have a transplanted kidney (confirm with trial site).
• People with a significant new level of protein leaking into their urine, as measured by a specific urine test.
• People whose immune system shows a high level of antibodies that could react against donor tissue, above 20% (confirm with trial site).
• People whose blood test shows a positive crossmatch result, meaning their immune system is likely to react against donor tissue (confirm with trial site).
• People with a kidney transplant who have developed new antibodies against their donor's tissue.
• Women who are pregnant, currently breastfeeding, or unwilling to use effective contraception during the study and for 4 months after it ends. Men who plan to father a child during the 24-month study or within 4 months after it ends, or who are unwilling to use effective contraception. Note: condoms used alone are not considered acceptable; other listed methods include the pill, implants, injections, or barrier methods with spermicide.
• People with a current or past active infection including hepatitis B, hepatitis C, HIV, or tuberculosis — including those who show signs of active infection in blood tests even without obvious symptoms.
• People who have never been exposed to the Epstein-Barr Virus, as shown by a negative IgG blood test.
• People who have had a serious fungal infection (invasive aspergillus, histoplasmosis, or coccidioidomycosis) within the past year.
• People with currently active cancer, unless a cancer specialist has confirmed they are in remission or cancer-free.
• People with a known current problem with alcohol or drug misuse.
• People whose routine blood counts are below normal levels, including low red blood cells, low white blood cells, low neutrophils, or low platelets — though people with low lymphocyte counts may still be considered if a blood specialist confirms there is no additional risk.
• People with serious existing heart disease, including a heart attack in the past 6 months, signs of reduced blood flow to the heart found on a heart test in the past year, or a significantly weakened heart pump (ejection fraction below 30%).
• People with a kidney transplant who have high cholesterol or high triglycerides that remain above certain levels despite medical treatment (LDL above 130 mg/dL or triglycerides above 200 mg/dL).
• People currently taking long-term oral steroids for a medical condition, except those on a very low dose (5 mg prednisone or equivalent) for hormone replacement purposes only.
• People who have taken part in another clinical trial and received an experimental treatment within the past 4 weeks.
• People who have received a live vaccine within the past 2 months.
• People with any other medical condition that the trial doctor believes would make participation unsafe.

Important: Always verify eligibility with the trial site directly before applying.