Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697953
Status:
WITHDRAWN
Last Update Posted:
2021-09-23
First Post:
2020-11-30
Brief Title:
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
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated - no participants were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEREGRINE
Brief 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 investigators judgment of visual function andor anatomic outcomes eg no change in visual acuity or any other signs of the disease eg 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 ie no change in visual acuity and other signs of disease eg 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 eg DAA due to reasons other than nAMD disease activity eg fibrosis geographic atrophy etc
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 investigators judgment of visual function andor anatomic outcomes eg no change in visual acuity or any other signs of the disease eg 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 ie no change in visual acuity and other signs of disease eg 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 eg DAA due to reasons other than nAMD disease activity eg fibrosis geographic atrophy etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None