Phase 1 Macular Degeneration Trial, Recruiting

Written by an AI model from the 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 50 or older, of any gender
• People who are willing and able to sign a written consent form agreeing to take part
• People who have been diagnosed with wet age-related macular degeneration (a condition where abnormal blood vessels grow under the retina) in the eye being studied, as confirmed by an eye doctor
• People who have active abnormal blood vessel growth (called CNV) affecting the central part of the retina in at least one eye — if both eyes are affected and meet the criteria, the eye with the worse vision will be chosen for the study
• People whose vision in the study eye falls within a specific range (roughly between 20/32 and 20/320 on a standard eye chart) when tested with the best possible glasses or contact lens correction
• People whose retinal scans show a certain level of retinal thickening (at least 250 microns in the central area, measured by a specific type of scan called SD-OCT)
• People whose retinal scans show fluid either under or within the retina
• People whose affected area of the retina is not larger than 12 disc areas (a measurement used by eye specialists) on imaging
• People where any bleeding under the retina makes up less than half of the total affected area, if bleeding is present
• People who have no scarring or tissue loss directly under the central part of the retina
• People with active leaking abnormal blood vessels that are too close to the centre of the retina for laser treatment to be used safely
• Women who cannot become pregnant (due to surgery or menopause), or women who could become pregnant but are using reliable birth control and are not currently pregnant or breastfeeding
• People who are able to follow the requirements of the study

Who may not be able to join:

• People who have other eye diseases affecting the back of the study eye, apart from wet macular degeneration
• People whose CNV lesion involves significant scarring, permanent damage, or bleeding covering more than half the affected area in the central retina of the study eye, in a way that might affect how well the treatment works
• People who have had bleeding inside the eye (vitreous haemorrhage), a certain type of retinal detachment, a tear in the retinal pigment layer involving the central retina, or a macular hole (stage 3 or 4) in the study eye
• People who do not have a natural or artificial lens in the study eye, or are missing the back part of the lens capsule
• People who have had certain eye surgeries in the study eye recently — including vitrectomy (an operation inside the eye) in the last month, cataract or LASIK surgery in the last 3 months, or who have planned cataract surgery scheduled during the study
• People with uncontrolled glaucoma (high eye pressure above 25 mmHg even with medication), advanced glaucoma with significant optic nerve damage, or who have had glaucoma filtering surgery in the study eye
• People who have had serious complications from eye surgery in the study eye within the past year
• People currently using or planning to use medications known to be harmful to the retina, lens, or optic nerve (examples include deferoxamine, chloroquine, hydroxychloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
• People with certain medical conditions, including: poorly controlled diabetes (HbA1c above 10%), a heart attack or stroke within the past 12 months, active bleeding disorders, major surgery within the past month or planned during the study, liver problems, uncontrolled high blood pressure, other unstable or worsening heart, lung, liver, or kidney disease, cancer, Parkinson's disease, or dementia
• People who have received certain eye injections (ranibizumab, bevacizumab, aflibercept, or pegaptanib) or intravenous bevacizumab in either eye within the past four months
• People who have received photodynamic therapy, laser treatment, or certain other treatments for macular degeneration in the study eye within the past 3 months
• People who have received steroid injections in or around the study eye within the past 3 months
• People currently receiving anti-VEGF treatment (a type of medication that targets abnormal blood vessel growth) given through the body rather than directly into the eye
• People who have had any device implanted in the eye within the past 12 months
• People whose blood or urine test results at the screening stage are significantly abnormal, in the opinion of the investigator
• People whose liver-related blood test results are two or more times above the normal upper limit at screening (this includes tests such as AST, ALT, alkaline phosphatase, GGT, bilirubin, and LDH)
• People with significantly reduced kidney function, based on a calculated measure of kidney filtering ability falling below 30 mL/min
• People with significant alcohol or drug misuse in the past 2 years, as judged by the investigator
• People who have previously participated in another clinical trial for wet macular degeneration involving a treatment given through the body, unless at least 3 months have passed since the last dose
• People who have any other significant medical condition that, in the investigator's opinion, could put them at risk, affect the study results, or raise concerns about their ability to take part
• People with a known allergy to fluorescein dye or to any ingredient in the study medication or other medicines used during the study
• People with an active eye infection (infectious conjunctivitis) in either eye
• Women who are currently pregnant or breastfeeding
• Women who could become pregnant and have not agreed to use adequate birth control for the entire duration of the study
• Post-menopausal women who cannot provide documentation showing their last menstrual period was at least 2 years before joining the study

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