Phase 3 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 have agreed to take part voluntarily and are able to attend scheduled clinic visits and follow the study procedures
• People who have been diagnosed with type 1 or type 2 diabetes and are between 18 and 80 years old (inclusive)
• People whose study eye has a diabetes-related swelling in the central part of the retina (the area responsible for detailed vision), confirmed by a specialised eye scan called an OCT
• People whose study eye shows a retinal thickness measurement above a certain level on OCT scanning (above 300 µm, or above 320 µm depending on the type of scanner used)
• People whose study eye has a vision level that falls within a specific range — roughly between 20/40 and 20/400 on a standard eye chart (meaning vision that is reduced but not absent)
• People whose other (non-study) eye has vision above a minimum level — roughly better than 20/320 on a standard eye chart

Who may not be able to join:

• People whose study eye has permanent structural damage to the central retina (such as scarring, significant loss of blood supply, or other changes) that would be likely to prevent vision from improving even if the swelling were treated
• People whose study eye has a membrane or pulling force on the retina surface that the investigator considers likely to prevent vision improvement
• People whose study eye has any condition other than diabetic macular swelling that could affect how the eye looks on examination or how vision is measured (for example, a blocked retinal vein, a detached retina, a hole in the macula, or abnormal blood vessel growth under the retina)
• People whose study eye is missing its natural lens entirely, or has a cloudy artificial lens implant (with some exceptions if laser treatment was performed at least one month beforehand — confirm with trial site)
• People whose study eye has uncontrolled pressure inside the eye (above 25 mmHg despite eye drops), or a history of surgery to reduce eye pressure, or planned eye pressure surgery during the study
• People whose study eye has previously had a specific type of surgery involving the gel inside the eye (vitreoretinal surgery) or a procedure to support the retina from outside the eye (scleral buckling)
• People whose study eye has had certain types of laser treatment to the retina within the past 3 months, or for whom such laser treatment is expected to be needed during the study
• People whose study eye shows abnormal new blood vessel growth on the iris (the coloured part of the eye) or other significant iris abnormalities
• People whose study eye has active advanced diabetic eye disease involving new blood vessel growth, bleeding into the eye, or retinal detachment
• People whose study eye has had surgery inside the eye within the past 3 months, or for whom such surgery is planned during the study
• People whose study eye has cloudiness or other problems affecting the eye's optical surfaces (such as corneal scarring, dense cataracts, or bleeding inside the eye) that would interfere with vision testing or retinal examination
• People whose study eye has received certain steroid injections or implants within specified time periods before the start of the study, or who have taken high-dose steroid tablets recently (the required timeframes vary depending on the type and route of steroid — confirm with trial site)
• People whose study eye has a high degree of short-sightedness (greater than -6.0 diopters), or whose eye measurements suggest an unusually long eye (axial length above 26mm) if prior prescription records are unavailable
• People who have a history of inflammation inside either eye (uveitis)
• People who have an active eye infection (bacterial, viral, fungal, or parasitic) in either eye
• People whose study eye has received injections of anti-VEGF medication (a type of treatment targeting abnormal blood vessel growth) within 90 days before being enrolled in the study, or who have received such treatment as a systemic (whole-body) therapy within that period
• People with significantly abnormal liver or kidney function based on blood tests, as defined by the trial's laboratory thresholds
• People with abnormal blood clotting results on specific laboratory tests
• People who test positive for active hepatitis B (with detectable virus levels above a certain threshold), active hepatitis C, HIV, or certain syphilis markers that are consistent with active infection
• People who have had a heart attack, stroke, or similar blood clot-related event in the 6 months before the first dose
• People with poorly controlled diabetes, defined as a blood sugar control marker (HbA1c) above 11%
• People with uncontrolled high blood pressure (above 160/95 mmHg despite medication)
• People who have had surgery within the past month with wounds that have not yet fully healed, or as otherwise determined by the investigator
• People who have a diagnosed systemic autoimmune disease (such as lupus or ankylosing spondylitis) or any serious uncontrolled medical condition, including active cancer, severe psychiatric illness, or severe heart, lung, or liver disease
• People who have a medical history, physical finding, or laboratory result that suggests the study drug may be unsafe for them or may interfere with study results (confirm with trial site)
• People who are known to be allergic to the study drug or its ingredients, or to fluorescein dye, povidone-iodine, or indocyanine green (substances used during eye examinations)
• People who have taken part in another clinical drug trial within 90 days before the first study dose (or within 5 half-lives of the previous investigational drug, if that is longer than 90 days)
• People who are currently pregnant, breastfeeding, or who test positive on a pregnancy test; and people of reproductive potential (male or female) who are unwilling to use an effective form of contraception throughout the study and for 3 months after the final visit
• People who have any other condition that the investigator considers a reason to exclude them from the trial

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