Phase 2 Retinal Vein Occlusion and Diabetic Macular Oedema 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:

• People who are willing and able to give written informed consent and follow all study requirements
• Adults aged 18 or older at the time of giving consent
• Women who are confirmed to have no childbearing potential, as defined by the Clinical Trial Facilitation Group guidelines (confirm with trial site)
• People whose eye(s) have clear media and pupils that dilate well enough to allow high-quality retinal imaging
• People who are willing to avoid unusually strenuous physical activity (such as heavy lifting, weight training, or intense aerobics) for at least 72 hours before each study visit

For people with a specific type of diabetic eye disease (NPDR), additional criteria apply:

• People diagnosed with moderately severe or severe non-proliferative diabetic retinopathy (a specific level of diabetic eye disease), without a certain type of diabetic swelling in the centre of the eye
• People whose vision in the study eye meets a minimum level on a standardised eye chart (roughly equivalent to 6/12 or 20/40 on a Snellen chart)

For people with a blocked vein in the eye (RVO), an additional criterion applies:

• People diagnosed with retinal vein occlusion whose symptoms began within 28 days before the first dose of the study treatment

Who may not be able to join:

• People who are unwilling or unable to attend all required study visits and complete all required tests and procedures, including follow-up
• People who have had a major medical or surgical procedure or significant physical trauma within 4 weeks before the first treatment, or who have major surgery planned during the study period (up to Day 120)
• People with a significant medical condition or disorder that, in the investigator's opinion, could put them at risk or affect the study results
• People who have previously been exposed to a laboratory-made version of a protein called Annexin A5
• People with a history of severe allergic reactions, or a known allergy to biologic medicines (laboratory-made proteins or similar treatments)
• People with uncontrolled high blood pressure (above specific levels that the trial site can confirm)
• People currently taking certain medicines that reduce blood vessel growth or corticosteroid medicines given throughout the body
• People with an untreated cancer that has spread to other parts of the body
• People with an active, serious infection or inflammation that would require antiviral or antibiotic treatment not completed before the screening visit, or that could affect their safety or study results
• People who have taken part in another clinical trial involving an experimental drug, device, or biological treatment within the past 3 months (or longer, depending on the treatment), or who plan to join another interventional trial during this study
• People with a history of blood clots or deep vein thrombosis within 3 months before the screening visit
• People currently taking blood-thinning or clotting-related medicines (low-dose aspirin is allowed beforehand but must be stopped at the time of consent, and may be restarted one day after the fifth treatment infusion)
• People who currently take benzodiazepine medicines (a type of sedative) every day
• People with significantly abnormal blood-clotting test results at the start of the study
• People with a history of certain autoimmune conditions that may produce specific antibodies that could interfere with the study treatment (such as antiphospholipid syndrome, lupus, rheumatoid arthritis, Behçet disease, or systemic sclerosis)
• People with an inherited blood disorder such as sickle cell disease or thalassemia
• People with a history of unstable heart disease or stroke within the past 3 months
• People with known kidney disease or kidney function below a certain level at the start of the study (confirm specific threshold with trial site)
• People currently misusing drugs or alcohol, or who smoke heavily (roughly 20 or more cigarettes per day or equivalent), in the investigator's opinion
• People with a known or confirmed chronic infection affecting the immune system, such as hepatitis B, hepatitis C, or HIV
• People with severe obesity, defined as a body mass index (BMI) of 40 or above at the time of giving consent
• People who have used certain medicines known to be harmful to the retina, lens, or optic nerve within 6 months before the screening visit (such as chloroquine, tamoxifen, or similar medicines — confirm full list with trial site)
• People with a known allergy or sensitivity to fluorescein dye (used in eye imaging), to any component of the study products, or whose pupils cannot be dilated; people with mild allergies that do not require treatment may still be eligible at the investigator's discretion

Eye-related criteria (either or both eyes):

• People with a severe defect in how the pupils respond to light (a specific eye nerve test result — confirm with trial site)
• People with eye pressure above 24 mmHg that is not controlled by medication or surgery at screening
• People with a recent history (within 6 months) or current presence of eye inflammation, uveitis, or active eye infection
• People with evidence of abnormal new blood vessel growth in the eye
• People whose non-study eye has vision below a certain level on the standardised eye chart (roughly equivalent to 6/24 or 20/80 on a Snellen chart)
• People with other eye conditions that, in the investigator's opinion, could affect the study results or require treatment during the study (a detailed list can be confirmed with the trial site)
• People who have received anti-VEGF injections into either eye within the past 6 months, or who are currently receiving them

Study eye only:

• People with evidence of significant bleeding in the central part of the retina
• People who have had laser treatment to the study eye within the past 6 months, or who are likely to need it during the study
• People who have had eye surgery or an injection into the study eye within the past 6 months, or cataract surgery within the past 3 months, or who have planned eye surgery during the study
• People with a recent (within 6 months) history or current evidence of herpes-related eye disease in the study eye

For people with diabetic eye disease (NPDR) only:

• People who have a certain type of diabetic swelling in the centre of the eye (in either eye) that the investigator considers suitable for anti-VEGF or laser treatment

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