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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT05161806
Eligibility Criteria:
Inclusion Criteria:
* Subjects ≥ 50 years of age at baseline
* Subjects diagnosed with nAMD (uni- or bilateral)
* Subjects already under IVT Eylea treatment (last injection of the induction period or maintenance phase)
Exclusion Criteria:
* Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator's judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis
* Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 26 mmHg, despite treatment with anti-glaucomatous medication)
* History of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of investigational product
* Visual Acuity Score (VAS) worse than 20/200 on a Snellen chart, the generally accepted level of legal blindness
* Receipt of any systemic anti-VEGF within the last 6 months prior to enrollment
* Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value ≥ 100 mmHg at Screening)
* Subjects who do not comply with the local COVID-19 regulations of the study site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05161806
Study Brief:
Protocol Section:
NCT05161806