A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration (OCTOPUS)

A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration (OCTOPUS)

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 studies.

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 Week 48.

Approximately 428 adult patients will be screened and included in approximately 75 centers in France.

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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 428 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm, open-label study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A One-year, Single-arm, Open-label, Multicenter Study Assessing the Anatomic Outcomes of Brolucizumab Assessed by OCT-A in Adult Patients With Neovascular Age Related Macular Degeneration
Actual Study Start Date: January 26, 2021
Estimated Primary Completion Date: January 3, 2022
Estimated Study Completion Date: September 12, 2022

Arms:
- Experimental: RTH258/Brolucizumab

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