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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT06660667
Eligibility Criteria:
Inclusion Criteria:
* Between 50 and 90 years of age
* Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)
* Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/32 and 20/400 and for expansion (Part II) between 20/25 and 20/200
* Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye
* Demonstrated a response to anti-VEGF treatment
Exclusion Criteria:
* Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
* History of active ocular infection in the study eye in 6 months prior to screening
* Active uncontrolled glaucoma in the study eye
* History of uveitis in either eye
* Current use of ocular corticosteroids in the study eye
* Previous gene therapy
* Any significant poorly controlled illness that would preclude study compliance and follow up
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT06660667
Study Brief:
Protocol Section:
NCT06660667