Phase 2 Macular Degeneration 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 aged 18 to 85 years old at the time of agreeing to take part
• People who are willing and able to give informed consent before any study procedures begin
• People who are willing and able to follow all study instructions, attend all visits, and complete all assessments
• People who have been diagnosed with macular oedema (swelling in the central part of the eye) in the study eye, caused by one of the following: non-infectious uveitis (eye inflammation not caused by infection), retinal vein occlusion (a blocked blood vessel in the eye), diabetic retinopathy (eye damage related to diabetes), or cataract surgery
• People who are taking steroid tablets or immune-suppressing medicines and have been on a stable dose for at least 3 months before the screening visit and throughout the study
• People whose central retinal thickness measurement is 350 micrometres or more (a measure of swelling in the eye, confirmed by a scan)
• People whose vision in the study eye falls within a specific range — not better than a certain level, and not worse than a certain level (confirm exact range with trial site)
• People whose eye is clear enough inside and whose pupil can be dilated enough for proper examination
• People who are willing to avoid certain medicines and treatments not allowed during the study
• People who agree to follow the contraception requirements from screening until 3 months after the last dose of the study drug, as follows:
  • People assigned female at birth who could become pregnant must agree to pregnancy testing at screening and before each dose, and must use an accepted form of contraception (such as hormonal contraception, an intrauterine device, abstinence, or a surgically sterilised partner)
  • People assigned female at birth who have had a hysterectomy, both ovaries removed, both tubes tied, or who have been postmenopausal for at least 12 months are not required to meet the pregnancy-related contraception criteria (postmenopausal status may need to be confirmed by a hormone blood test)
  • People assigned male at birth whose partner could become pregnant must either be surgically sterile for at least 3 months before starting the study drug, or ensure their partner uses contraception as listed above, and must also use a condom; they must not donate sperm from screening until 3 months after the last dose
  • People who have chosen complete abstinence as their usual lifestyle for at least one year are exempt from contraception requirements, but must agree to use contraception if they become sexually active during the study

Who may not be able to join:

• People who have cloudiness or blockages inside the eye (such as cataracts, scarring, or cloudy vitreous gel) that would prevent proper eye examination or imaging
• People who have received certain biological medicines (such as TNF-blockers or B-cell blockers) in the 90 days before the study starts, or who plan to receive them during the study
• People who have received or plan to receive the chemotherapy medicines cyclophosphamide or chlorambucil during the study
• People who have received injections into the eye (such as anti-VEGF injections) in the 90 days before the study starts, or who plan to receive them during the study
• People who have received steroid injections behind or around the eye in the 90 days before the study starts, or who plan to receive them during the study
• People who have a steroid-releasing implant in the study eye, unless enough time has passed since the implant was placed or removed (the required time varies by implant type — confirm with trial site); note that steroid eye drops are generally permitted if the dose has been stable for at least 3 months
• People who have had eye surgery (including cataract removal, laser treatment, or retinal surgery) in the study eye within 90 days before the study starts, or who plan to have surgery during the study
• People who have had a laser procedure to the lens capsule of the study eye within 30 days before the study starts, or who plan to have one during the study
• People whose eye pressure in the study eye is 25 mmHg or higher, unless they have glaucoma that is well controlled with no more than one eye pressure-lowering drop and their pressure is below 25 mmHg
• People whose eye pressure in the study eye is abnormally low (below 6 mmHg)
• People who have no natural lens in the study eye, or who have a lens implanted at the front of the eye
• People who have thinning or bulging of the white of the eye, or a condition called keratoconus (irregular cornea shape), in the study eye
• People who have any cancerous growth in either eye
• People who have any other significant eye disease that could interfere with the study assessments
• People who have an active eye, surrounding eye area, or body-wide infection, a temperature above 38.0°C, or who have used antibiotic medicines or eye drops within 14 days of the study starting
• People with certain psychiatric conditions that the study doctor believes would prevent them from following the study requirements, including a current or past history of psychosis or bipolar disorder, a need for lithium treatment, or a history of suicide planning within the past 5 years
• People who have any significant abnormal result from medical tests at screening (such as blood tests, urine tests, or heart tracing) that the study doctor believes could interfere with the study or their safety
• People who have any other medical condition or health problem that the study doctor believes could put them at risk, affect the study results, or make participation difficult
• People who have taken part in another clinical trial of an investigational medicine or device within 90 days before the study starts, or who plan to join another such trial during the study or within 120 days of the study starting
• People who have a significant blood clotting problem that the study doctor believes could make it difficult to collect the blood samples required by the study
• People who have a known allergy or hypersensitivity to the study medicine, any of its ingredients, any steroids, or any diagnostic or standard care products likely to be used during the study (such as fluorescein dye, dilating drops, antibiotic drops, or povidone)
• People who are pregnant, breastfeeding, or planning to become pregnant during the study

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