Phase 4 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:

• Adults aged 18 or older who have been diagnosed with type 1 or type 2 diabetes
• People whose study eye has diabetic swelling at the centre of the retina, confirmed by a specific scan measurement of 320 μm or more on a Spectralis device
• People whose vision in the study eye falls within a specific range (roughly equivalent to 20/25 to 20/400 on a standard eye chart), where the vision loss is mainly caused by diabetic swelling in the eye
• People who are willing and able to attend clinic visits and follow study-related procedures
• People who are able to provide signed informed consent, either personally or through a legally accepted representative
• People who have previously had vitrectomy surgery (a specific type of eye surgery)

Who may not be able to join:

• People whose retinal swelling is caused by something other than diabetes, in either eye
• People whose study eye has previously received any experimental injection-based treatment, including gene therapy, at any point in the past
• People with elevated eye pressure of 28 mmHg or higher in the study eye
• People who have previously had glaucoma drainage surgery
• People who have had an eye surface infection (such as eyelid, cornea, or eye membrane infection) in either eye within the 4 weeks before the screening visit
• People who have had any inflammation or infection inside either eye within 6 weeks before the screening visit
• People with a history of uveitis (inflammation inside the eye) not caused by an infection, in the study eye
• People whose study eye has scar tissue or pulling on the central retina that is thought to be affecting central vision, as seen on examination or scan
• People whose study eye currently shows abnormal new blood vessel growth on the iris, bleeding in the eye, or a type of retinal detachment caused by pulling tissue
• People who have had a cornea transplant or have a corneal disease in the study eye
• People whose study eye has any other eye condition that, in the investigator's opinion, could increase risks or interfere with the treatment or study results
• People whose study eye has permanent structural damage to the central retina that would likely prevent vision improvement even if the swelling resolved
• People for whom the required eye scans or imaging cannot be obtained due to cloudiness in the eye, allergy to the dye used in one of the tests, or difficulty accessing a vein for the dye injection
• People with any other medical condition, abnormal test result, or health finding that would make the study treatment risky or make the results difficult to interpret
• People whose diabetes is poorly controlled, defined as a blood sugar marker (HbA1c) above 14%
• People who have had a stroke or heart attack within the 24 weeks before the screening visit
• People with a known allergy or sensitivity to any ingredient in the study treatment
• People who have taken part in another clinical study involving a drug or device within 30 days before the screening visit
• Women who are pregnant or breastfeeding
• Men or women who are capable of having children and are unwilling to use highly effective contraception from before the first treatment through the end of the study

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