Phase 2 Glaucoma 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:

All participants must meet these general criteria:

• People who are willing to take part and have signed a written consent form
• People aged 18 to 75 years old (inclusive), of any gender
• People who have been diagnosed with primary open-angle glaucoma (a common type of glaucoma) for at least 1 year
• People who are generally in good health with no significant medical conditions, based on their medical history, physical check-up, and blood/lab tests done at screening
• People who are willing to follow all required tests, visits, and treatment plans in the study
• People who agree to attend a follow-up safety visit 1 year after joining

Additional criteria for Trial Group 1 only:

• People whose target eye has no remaining vision
• People whose eye pressure in the target eye is higher than 21 mmHg but no higher than 50 mmHg, even after using 2 or more eye pressure-lowering medicines together

Additional criteria for Trial Group 2 only:

• People whose eye pressure in the target eye is higher than 21 mmHg but no higher than 40 mmHg, even after using 2 or more eye pressure-lowering medicines together
• People whose target eye has a fully open drainage angle, as measured by a special eye examination (Shaffer gonioscopy score greater than 3) (confirm with trial site)
• People whose best corrected vision in the target eye meets a minimum level of at least 0.3 on the logMAR scale (confirm with trial site)

Who may not be able to join:

General exclusion criteria:

• People whose glaucoma is caused by another medical condition (secondary glaucoma)
• People with any active or returning infection or inflammation inside the eye, such as uveitis
• People with severe dry eye or a significant active corneal disease in the target eye
• People whose eye pressure cannot be measured for any reason
• People with known allergies to the medicines or their ingredients being used in this study
• People who have had an eye injury in either eye within the 6 months before screening, or eye surgery or non-corrective laser treatment within the 3 months before screening
• People with a significant history of herpes simplex or herpes zoster infections affecting the eye
• People who test positive for Hepatitis B, Hepatitis C, Epstein-Barr virus, or cytomegalovirus (CMV)
• People who test positive for syphilis or HIV antibodies
• People with severe active infections anywhere in the body, including bacterial, viral, fungal, malaria, or parasitic infections
• People with any past or present cancer, blood cell disorders, or immune deficiency conditions
• People with serious uncontrolled medical conditions such as active hepatitis, liver disease, uncontrolled high blood pressure, heart attack or heart inflammation, irregular heartbeat, stroke, kidney failure, uncontrolled diabetes, thyroid disorders, severe lung conditions, or similar illnesses
• People with any serious mental illness
• People who have taken part in another clinical trial and received a medicine or medical device as part of that trial within 1 month before screening
• People who are pregnant, breastfeeding, planning to become pregnant, or who are of childbearing age and not using a medically approved form of contraception (this does not apply to people who have been through menopause for at least 1 year, or who have had a surgical sterilisation procedure at least 3 months prior)
• People whom the trial investigator considers unsuitable for the study for any other reason

Additional exclusion criteria for Trial Group 1 only:

• People whose blood test shows a high level of antibodies against AAV2 (a virus used to deliver the treatment) — specifically, a level higher than 1:200 at screening (confirm with trial site)

Additional exclusion criteria for Trial Group 2 only:

• People who have certain retinal (back of the eye) conditions in the target eye, including unexplained vision loss in a quarter of the visual field, wet age-related macular degeneration, retinal vein blockage, fluid in the central part of the retina, a hole in the central retina, abnormal blood vessel growth in the retina, or central serous retinopathy
• People with a very narrow or closed drainage angle in the eye, certain types of glaucoma affecting the drainage angle, significant scarring in the front part of the eye, or a history of certain angle-related surgeries or laser treatments (confirm with trial site)
• People whose cornea (the clear front surface of the eye) is thinner than 480 micrometres or thicker than 620 micrometres
• People with severe loss of visual field, for example where the average deviation is worse than -12 dB, or where vision is deteriorating faster than 2 dB per year (confirm with trial site)
• People whose target eye has already had surgery or laser treatment for glaucoma inside the eye
• People whose blood test shows a high level of antibodies against AAV2 — specifically, a level higher than 1:400 at screening (confirm with trial site)

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