Neovascular age-related macular degeneration (nAMD) is characterized by the presence of
choroidal neovascularization (CNV). Choroidal neovascularization consists of abnormal blood
vessels originating from the choroid and can lead to hemorrhage, fluid exudation, and
fibrosis, resulting in photoreceptor damage and vision loss.
The safety and efficacy of brolucizumab has been demonstrated in 2 randomized, multicenter,
double-masked, active controlled Phase 3 studies in nAMD patients (RTH258-C001 and
RTH258-C002). Anatomical changes were evaluated in these studies using spectral domain
optical coherence tomography (SD-OCT), which relied on indirect parameters for the diagnosis
of active CNV. The OCT-angiography (OCT A) that directly visualize retinal circulation and
image CNV and vascular diseases of the retina was not included in previous brolcuizumab
This single-arm, open-label, multicenter study is being performed to evaluate the efficacy
and safety of brolucizumab 6 mg in patients with nAMD.
OCT-A will be used in this study to assess the morphological response of patients to
brolucizumab in terms of percentage change in CNV lesion area in the short term (i.e. at Week
12) and in the long term (i.e. at Week 48), as well as changes in other OCT-A features up to
Approximately 428 adult patients will be screened and included in approximately 75 centers in
The maximum study duration for 1 patient is 48 weeks.
Patients will be required to attend 6 mandatory study visits: Screening/Baseline Visit (Day
1), Week 4, Week 8, Week 12, Week 16 and Week 48 visits. The timing of the interim visits
between Week 16 and Week 48 will depend on the patient's injection regimen, i.e. every 8
weeks or every 12 weeks according to disease activity assessed by the investigator.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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