Phase 2 Macular Degeneration Trial, Not Yet 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 are 60 years of age or older at the time of screening.
• People who have been diagnosed with dry (non-exudative) age-related macular degeneration (AMD) in both eyes, with signs such as drusen (small deposits under the retina).
• People whose affected eye has an area of geographic atrophy (GA — a specific type of damage to the retina) that falls within a certain size range, as measured by a specialist imaging scan, and meets specific location and visibility requirements confirmed by a central reading centre.
• People whose affected eye shows a particular pattern of activity at the edge of the damaged retinal area, visible on a special eye scan called autofluorescence imaging.
• People whose affected eye has a certain minimum level of vision (at least 20/70 on a standard Snellen eye chart) at both the screening and baseline visits.
• People whose affected eye has a minimum level of vision under low-light conditions, as measured by a specific eye test, at both the screening and baseline visits.
• People who are able to complete a special visual field test called microperimetry, including being able to detect the target light and maintain steady eye focus.
• People who are able to take the study medication themselves, or who have a suitable family member or carer who can help administer it.
• People who are willing and able to give written informed consent and to attend all required study visits, follow instructions, take the study medication daily, and keep a dosing diary.
• People whose eyes are clear enough and whose pupils can dilate enough to allow good-quality images to be taken, as assessed by the investigator.
• People whose other (non-study) eye may have AMD with or without GA, or GA affecting the central part of the retina — ongoing treatment with certain eye therapies in that eye is permitted.
• People who have received vaccinations against Neisseria meningitidis and Streptococcus pneumoniae at least two weeks before starting the study treatment.
• People who have received, or are able to receive, a vaccination against Haemophilus influenzae type b, where this vaccine is available and in line with local regulations.
• People whose body mass index (BMI) falls between 18 and 40.
• People who are capable of becoming pregnant and are not confirmed to be post-menopausal must be using appropriate contraception; male participants whose partners could become pregnant must agree to use highly effective contraception during the study and for one month after the last dose of the study medication.
• People who agree not to donate eggs or sperm during the study and for one month after the last dose of the study medication.

Who may not be able to join:

• People whose retinal damage is caused by something other than AMD, such as severe short-sightedness or inherited retinal conditions like Stargardt disease or pattern dystrophy, in either eye.
• People who have signs of wet (exudative) AMD or abnormal blood vessel growth under the retina in either eye — though prior treatment for this in the non-study eye may be acceptable if the last injection was more than two years ago.
• People whose study eye has previously been treated with light-based therapy (photodynamic therapy) or laser treatment to the central part of the retina.
• People whose study eye has a current blockage of a retinal vein (retinal vein occlusion).
• People whose study eye has bleeding in the jelly-like fluid inside the eye (vitreous haemorrhage).
• People who have a history of retinal detachment in the study eye.
• People who have at least moderate diabetic retinopathy in either eye (mild diabetic retinopathy or a history of diabetes without eye involvement is not automatically disqualifying).
• People who have any other retinal condition in either eye that, in the investigator's opinion, would affect the assessment of GA or make follow-up visits impractical.
• People who have a history of herpes infection affecting either eye.
• People who have active inflammation inside either eye (uveitis or vitritis).
• People who have a history of uveitis linked to an autoimmune condition or with no known cause, in either eye.
• People who have an active eye infection (such as conjunctivitis, keratitis, or similar) in either eye.
• People whose level of short-sightedness is greater than 6 diopters, or whose eye length is greater than 26 mm, in either eye.
• People who have had eye surgery (including lens replacement) within three months before being assigned to a treatment group, in either eye.
• People who have had a specific type of laser eye procedure (YAG laser) within one month before being assigned to a treatment group, in either eye.
• People who have previously had an infection with Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae type b despite vaccination.
• People with a known history of HIV, or active hepatitis B or C that has not been successfully treated.
• People with a known ongoing immune deficiency condition.
• People who have previously taken part in a retinal gene therapy clinical trial where the therapy was given to either eye.
• People who have had injections into either eye for any condition other than AMD — although prior injections for wet AMD in the non-study eye are allowed if the last injection was more than two years ago.
• People whose study eye has previously been treated for AMD using surgery, radiation, or laser (other than nutritional supplements), unless they were previously treated with Izervay or Syfovre and at least 6 months have passed since their last treatment, and they experienced no eye-related side effects from those treatments.
• People who have used immune-suppressing or immune-modifying medications (such as steroids taken by mouth, or certain biological drugs) within the past 90 days or within a specific washout period (inhaled, topical, or joint-injected steroids are generally not disqualifying).
• People who have used systemic complement inhibitor medications (a specific class of drug related to the immune system) within 30 days before the first dose, or within a certain washout period.
• People with any unstable or significant medical condition that, in the investigator's opinion, could put them at risk or interfere with their participation.
• People whose heart's electrical activity shows a specific abnormality (prolonged QTc interval above a certain threshold) on a heart tracing (ECG) at screening or baseline.
• People who have had a significant heart event within the last two years.
• People with significantly abnormal liver function test results at screening or baseline.
• People with a low platelet count below a specified level.
• People with a low haemoglobin (a measure of red blood cells) below a specified level.
• People with a history of end-stage liver or kidney disease requiring dialysis or transplant.
• People with a known allergy or sensitivity to the study medication or similar drugs, or a clinically significant sensitivity to fluorescein dye used in eye imaging.
• People with a history of alcohol or drug misuse within the last five years.
• People who are currently taking certain medications that affect how the study drug is processed by the body (specific enzyme inhibitors, inducers, or certain drug transport inhibitors).
• People who are currently taking part in any other clinical trial.

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