Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT07215234
Eligibility Criteria:
Inclusion Criteria:
* 60 years old or above
* Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)
* Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200
* Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II
Exclusion Criteria:
* GA in the study eye caused by a disease different than AMD
* Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye
* Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
* Current or history of systemic complement targeting treatment in the past 12 months
* Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye
* History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye
* History of active ocular infection in the study eye in 6 months prior to screening
* Presence of active ocular or periocular infections
* Active uncontrolled glaucoma in the study eye
* History of uveitis or scleritis in either eye
* Previous gene therapy in either eye
* Any significant poorly controlled illness that would preclude study compliance and follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07215234
Study Brief:
Protocol Section:
NCT07215234