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:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT04764656
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of nAMD
2. Male and Female patients with ≥40 years of age at index
3. Receipt of at least one injection of brolucizumab during the recruitment period
4. Signed written informed consent
Exclusion Criteria:
1. Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
2. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
3. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at Screening
4. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
5. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
6. Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
7. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
8. Patients participating in parallel in an interventional clinical trial
9. Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
10. Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline
11. Subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
110 Years
Study:
NCT04764656
Study Brief:
Protocol Section:
NCT04764656