NCT04764656

Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal

Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration (nAMD) in Portugal

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.

Detailed description

Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given. The baseline visit will be used to assess eligibility and collect baseline characteristics information. The study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). The follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation. Retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection.

Conditions

• Neovascular Age-related Macular Degeneration (nAMD)

Interventions

Type	Name	Description
DRUG	Brolucizumab	There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Timeline

• Start date: 2021-05-10
• Primary completion: 2024-02-16
• Completion: 2024-02-16
• First posted: 2021-02-21
• Last updated: 2025-03-25

Locations

11 sites across 1 country: Portugal