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 who are 55 years of age or older at the time of screening.
• People who are able and willing to give their consent to participate and attend all required study visits.
• Women or intersex individuals who are either past menopause for at least 12 months, have had surgery that prevents pregnancy, or are willing to use 2 forms of effective contraception during the study and for at least 90 days after the last dose; a negative pregnancy test is also required at screening and before each dose for those who could become pregnant.
• Men or intersex individuals with partners who could become pregnant must be willing to use approved contraception methods and not donate sperm during the study and for at least 90 days after the last dose.
• People who are currently taking an eye health supplement called AREDS, AREDS2, or a similar product must be willing to continue taking it throughout the study; people who are not currently taking such a supplement must be willing to continue not taking one — either way, a consistent approach must be agreed upon.
• The eye being studied must have a vision level of at least 24 letters on a standard eye chart (ETDRS) at screening.
• The pressure inside the eye being studied must be 22 mmHg or lower at screening.
• The eye being studied must have a specific type of geographic atrophy (GA) — an area of damage at the back of the eye linked to age-related macular degeneration (AMD) — that does not affect the very centre of the retina and has no certain type of abnormal blood vessel growth (confirm with trial site).
• The area of GA in the study eye must fall within a specific size range, as confirmed by a central review centre.
• If the GA in the study eye appears in more than one spot, at least one of those spots must meet a minimum size requirement, as confirmed by the central review centre.
• The GA in the study eye must be close to, but not covering, the central point of the retina, within a specific distance, as confirmed by the central review centre.
• The entire GA area in the study eye must be fully visible and able to be imaged on a standard eye scan, and must not connect with an area of tissue loss around the optic nerve, as confirmed by the central review centre.
• A specific pattern of light-and-dark activity at the edge of the GA area in the study eye must be present, as confirmed by the central review centre.
• The other eye (not the study eye) must have a vision level of at least 19 letters on a standard eye chart (ETDRS) at screening.

Who may not be able to join:

• People who are currently taking part in, or plan to take part in, another clinical trial or using another experimental drug or device within at least 6 months before enrolling or during the study, unless the study sponsor gives written approval.
• People who have previously had gene therapy for an eye condition, or who plan to take part in a gene therapy trial during the study.
• People who are currently using, or plan to use, certain medications that affect the immune system's complement pathway (systemic complement inhibitors) during the study.
• People with any eye or general health condition that, in the investigator's opinion, would make participation unsafe or affect the reliability of study results.
• People who have used certain medications known to be harmful to the lens, retina, or optic nerve (including but not limited to specific antibiotics and other drugs) within 90 days before screening, or who expect to use them during the study (confirm with trial site for the full list).
• People who have ever previously been treated with a medication called pentosan polysulfate (also known as Elmiron®).
• People who have a known allergy to fluorescein dye, povidone iodine, or any ingredient in the study drug.
• People who are currently pregnant, planning to become pregnant, or are breastfeeding at the time of screening or during the study.
• People with an active infection in or around the study eye.
• People for whom an injection into the study eye would be medically unsuitable (confirm with trial site).
• People who have cloudiness or other issues in the study eye that affect vision or prevent clear imaging of the retina, as determined by the investigator.
• People who have received certain types of injections into the study eye previously, with the exception of certain FDA-approved treatments; those who received FDA-approved complement inhibitors must not have had them within 12 weeks before screening.
• People who have had certain types of retinal surgery (such as a scleral buckle or vitrectomy) in the study eye; note that laser treatment for a retinal tear or hole performed 3 or more months before screening is not excluded.
• People who have had certain types of glaucoma surgery (such as trabeculectomy or a tube shunt) in the study eye; note that glaucoma laser procedures performed at least 6 months before screening are not excluded.
• People who have had a specific type of laser eye procedure (YAG capsulotomy) in the study eye within 1 month before screening.
• People who have planned or expected cataract surgery in the study eye during the study period.
• People who are missing the lens and a specific membrane at the back of the eye in the study eye (confirm with trial site).
• People who have any current or past evidence of the "wet" form of AMD in the study eye, including certain types of blood vessel leakage or tissue tears at the back of the eye, as assessed by the investigator and confirmed by the central review centre.
• People who have any significant retinal disease other than AMD in the study eye, excluding certain minor degenerative conditions.
• People who have had any other eye surgery in the study eye (including lens replacement) within 3 months before screening.
• People who have previously had radiation treatment directed at the study eye area, including certain laser-based therapies.
• People whose other eye (not the study eye) is expected to receive injections during the study for GA treatment with agents other than FDA-approved complement inhibitors.
• People who have active inflammation inside either eye, or a history of uveitis (eye inflammation) or endophthalmitis (serious eye infection) in either eye.
• People who have GA in either eye caused by something other than AMD.
• People who have any eye condition in either eye that is likely to require surgery during the study period.

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