Phase 2 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 60 years or older
• People who have been diagnosed with geographic atrophy (GA) of the macula caused by age-related macular degeneration (AMD) in one or both eyes
• People whose vision in the study eye measures 50 letters or better on a standard eye chart (roughly equivalent to 20/100 on a Snellen chart)
• People whose eye has clear enough media, adequate pupil dilation, and stable enough fixation to allow good quality imaging, as judged by the investigator
• People who have already been receiving Syfovre injections in the study eye every 6–8 weeks for at least 6 months but no more than 24 months, with at least 2 injections in the 6 months before screening
• People whose GA lesion in the study eye meets specific size and location requirements confirmed by specialised eye imaging: the total affected area must be between 2.5 and 17.5 mm², the full lesion must be visible within the imaging window, and the lesion must not reach the central point of the fovea (the centre of the eye)
• People whose eye imaging shows a specific pattern of brightness around the edges of the GA lesion on a specialised scan called fundus autofluorescence (FAF) — the absence of this pattern would make someone ineligible
• People who have received vaccinations against four specific bacteria (Streptococcus pneumoniae, Haemophilus influenzae type B, and two types of Neisseria meningitidis) within the past 5 years, or who are willing to receive these vaccinations at least 14 days before the first dose
• Women who are not able to become pregnant, or women who could become pregnant but have a negative pregnancy test at screening and agree to use contraception and not breastfeed for the duration of the study
• Men who are surgically sterile or who agree to use highly effective contraception from screening through the end of the study
• People who are willing and able to give informed consent and attend all required study visits

Who may not be able to join:

• People with uncontrolled or clinically significant history of serious conditions affecting the gut, kidneys, liver, lungs, nervous system, heart, hormone systems, blood, or with active cancer or severe allergic disease
• People with a history or current presence of liver cirrhosis or other liver disease that could increase the risk of liver problems from the study drug
• People with a history or current presence of a systemic autoimmune condition (except well-controlled Hashimoto's thyroiditis, a common thyroid condition)
• People with a known allergy, hypersensitivity, or prior serious reaction to siRNA-based therapies or any ingredients in the study drug
• People with certain abnormal heart test results, including a heart rate outside 40–100 beats per minute, irregular heart rhythm, certain abnormalities on an ECG (heart tracing), or recent signs of a heart attack or unstable chest pain
• People with certain abnormal liver blood test results above the accepted threshold levels
• People with reduced kidney function below a specific level as measured by a standard kidney function calculation
• People with a history of cancer that has not been successfully treated at least 1 year before enrolment (skin cancers such as basal cell or squamous cell carcinoma are generally not excluded)
• People with a history of recurring or unexplained infections, HIV, hepatitis B, hepatitis C, or meningococcal infection
• People who have had a fever or any active infection (including COVID-19 or an infection requiring antibiotics) within 30 days before screening
• People with current drug or alcohol misuse or dependence, in the opinion of the investigator
• People who intend to donate sperm during the study or within 90 days after the last dose
• People who have previously received the study drug APL-3007
• People who have taken part in another clinical trial involving an investigational drug or medical device within a specified washout period before screening
• People with poor vein access or skin conditions, tattoos, or lesions at the intended injection site that could interfere with the injections or assessments
• People with any condition that, in the investigator's opinion, would make participation unsafe or interfere with the study
• People who have received a live vaccine (other than seasonal flu) within 30 days before the first dose
• Women who are pregnant or breastfeeding
• People with medical or psychiatric conditions that, in the investigator's opinion, would make regular follow-up unlikely or participation unsafe
• People whose GA is caused by something other than AMD (such as Stargardt disease, cone rod dystrophy, or medication-related macular damage) in either eye
• People who have a history of abnormal blood vessel growth under the retina (choroidal neovascularisation) in the study eye, or related signs on imaging
• People with an active eye disease in the study eye that could affect vision or confound results, such as uveitis, significant scar tissue on the retina, a full-thickness hole in the macula, or uncontrolled glaucoma
• People who have received an injection into the study eye in the 3 months before screening, except for Syfovre injections
• People who have used any other investigational GA treatment in either eye within 3 months (or 5 half-lives of that drug, whichever is longer) before screening
• People who have had laser treatment in the macular area of the study eye
• People with any other eye condition in the study eye that may need treatment or surgery during the study, or that could affect vision during the study period

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