OBservationaL stUdy to Evaluate Fluid reSolution and Effectiveness in Patients Receiving Beovu (Brolucizumab) Under KeY Treatment Schemes in Neovascular Age-related Macular Degeneration and Visual Impairment Due to Diabetic Macular Edema

CRTH258ADE02

This study is a prospective, non-interventional, multicenter, open-label study in nAMD and DME patients being treated with brolucizumab according to the EU SmPC. An observational study design, without a strict, mandated visit schedule or mandated treatment regimen was chosen as the most appropriate to collect available data in a real life setting. For that reason, this NIS does not impose a therapy protocol, diagnostic/therapeutic procedure or a visit schedule. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care and will take place as per investigator's discretion. This includes e.g. visit frequency, injection frequency and types of assessments performed - only data from routine medical practice will be collected as part of the study.

2020-11-05

2025-12-20

2025-12-20

Active (not recruiting)

573

Inclusion Criteria: The unit of analysis is patient-eye, i.e. all criteria should be applied to the study eye, unless otherwise specified. Patients will be included in the study if they fulfil the following requisites: 1. Diagnosis of nAMD or visual impairment due to DME 2. Male and Female nAMD and DME patients with ≥18 years of age at index 3. Decision to treat with brolucizumab at baseline visit 4. Signed written informed consent 5. Patients for whom a therapy with brolucizumab is medically indicated 6. Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening Exclusion Criteria: 1. Patients that have any contraindication or are not eligible for treatment with brolucizumab as according to the SmPC 2. Patients treated for RVO or CNV other than nAMD 3. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date 4. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion (nAMD) 5. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date 6. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date) 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. Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3-month period prior to baseline 11. Prior use of intraocular or periocular corticosteroids in the study eye provided at least 4 months prior to baseline 12. Pregnancy and breast-feeding

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 573, 'type': 'ACTUAL'}}

2024-03-28