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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT04423718
Eligibility Criteria:
Inclusion Criteria:
* Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
* Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
* BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
* Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
* Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
* Other protocol-specified inclusion criteria.
Additional inclusion criteria for Year 3:
* At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).
* Participant is enrolled at a site that participates in the extension period.
Exclusion Criteria:
* Causes of CNV other than nAMD in the study eye.
* Scar, fibrosis, or atrophy involving the central subfield in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
* Uncontrolled glaucoma (defined as IOP \>25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
* History of idiopathic or autoimmune uveitis in the study eye.
* Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
* History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
* Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
* Uncontrolled blood pressure (defined as systolic \>160 mmHg or diastolic \>95 mmHg).
* Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.
* Other protocol-specified exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04423718
Study Brief:
Protocol Section:
NCT04423718