NCT04697953

Efficacy and Safety of Brolucizumab 6mg in a Treat and Extend Regimen in Patients With Neovascular Age-Related Macular Degeneration (nAMD) With Prior Anti-VEGF Exposure (PEREGRINE)

Brolucizumab Switch and Extend Ph IIIb Study: A Canadian, Multi-center, Single-arm, Open Label Study Assessing the Efficacy and Safety of Brolucizumab 6mg in a Treat and Extend Regimen in Patients With Neovascular Age-Related Macular Degeneration (nAMD) With Prior Anti-VEGF Exposure (PEREGRINE)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess whether switching nAMD patients from aflibercept to brolucizumab would permit extension of treatment intervals while maintaining treatment efficacy, thereby alleviating the treatment burden on patients, caregivers, healthcare professionals (HCPs), and medical institutions.

Detailed description

This study is a 104 week, single-arm, open label, Ph IIIb multicenter study in Canadian nAMD patients who will be switched from aflibercept 2mg to brolucizumab 6mg and extended using a Treat \& Extend regimen by up to 2 week intervals assessing the durability, effectiveness, and safety of brolucizumab 6mg. During the baseline visit, patients who consent will undergo an assessment to evaluate their eligibility based on the inclusion and exclusion criteria. Patients that meet all of the inclusion criteria and none of the exclusion criteria will be eligible to participate. The study is expected to recruit 423 patients. If both eyes are eligible as per the inclusion and exclusion criteria, the eye with worse visual acuity should be selected for the study eye, unless the investigator deems it more appropriate to select the eye with better visual acuity. nAMD patients stable on aflibercept q6w, q8w, q10w or q12w, will be switched to brolucizumab 6mg intravitreal injections. Disease stability is characterized by no disease activity based on the disease activity assessment (DAA) criteria (defined below) and on the investigator's judgment of visual function and/or anatomic outcomes (e.g. no change in visual acuity) or any other signs of the disease (e.g. SRF, hemorrhage, leakage, etc.). At baseline patients will be treated with brolucizumab 6mg in the study eye only and will be scheduled for the next treatment at the pre-baseline dosing interval. At subsequent visits, the treating physician will perform a disease activity assessment (DAA) to establish treatment extension based on the following criteria: * Decrease in BCVA of ≥ 5 letters compared to previous visit or, * Decrease in BCVA of ≥ 3 letters and CSFT increase ≥ 75μm compared to previous visit or, * Any intraretinal cysts (IRC) / intraretinal fluid (IRF) compared to previous visit If the treating physician determines that there is no nAMD disease activity based on visual and anatomical assessments, i.e. no change in visual acuity and other signs of disease (e.g. IRF, SRF, hemorrhage or leakage), the following treatment can be extended by up to 2 weeks. Treatment extensions can occur at each subsequent visit to a maximum of 20 weeks between treatments. If disease activity is identified at any study visit the interval should be shortened. If the patient is on a dosing regimen of q12w or less, the dosing interval will be shortened by two (2) weeks. For patients on a regimen of greater than q12w, the dosing interval will be shortened by four (4) weeks. If the treatment interval is currently q6w and patient fails DAA, they are not forced to discontinue, and they can be reduced to a treatment interval below q6w. If a patient fails the first attempt to extend, the patient will have two more attempts for extension during the study. If the patient shows significant disease activity after the second attempt for extension, injection intervals will be fixed to the previous stable, disease free interval until the end of the study. At any point during the study, the treatment interval can also be maintained, if the investigator deems that the patient will not benefit from treatment interval adjustment (e.g., DAA due to reasons other than nAMD disease activity \[e.g. fibrosis, geographic atrophy, etc.\]).

Conditions

• Age-related Macular Degeneration (AMD)

Interventions

Type	Name	Description
DRUG	brolucizumab	Pre-filled Syringes for intravitreal injection

Timeline

• Start date: 2021-05-31
• Primary completion: 2021-06-21
• Completion: 2025-05-31
• First posted: 2021-01-06
• Last updated: 2021-09-23