Age-related Macular Degeneration (AMD) Clinical Trial
— PEREGRINEOfficial 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)
Verified date | September 2021 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 31, 2025 |
Est. primary completion date | June 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Written informed consent must be obtained personally or by a legal proxy before any assessment is performed. - Patients who are = 50 years of age - Confirmed diagnosis of nAMD in the judgement of the investigator - Patients currently being treated with intravitreal injections of aflibercept 2 mg on 6-12 week dosing intervals for nAMD for a period no longer than 24 months from date of diagnosis. - Documentation of at least one attempt to extend past the current dosing interval of aflibercept 2mg and return to stable condition at the current predefined interval - BCVA score must be = 78 (20/32) and =24 (20/320) letters using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity charts at baseline Exclusion Criteria: - nAMD patients with disease activity at baseline - Concomitant conditions or ocular disorders in the study eye at baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period. - Simultaneous participation in a study that includes administration of any investigational drug or procedure, other than brolucizumab. - Any active intraocular or periocular infection or active intraocular inflammation, at baseline (study eye) or in the preceding 6 months - Uncontrolled glaucoma defined as intraocular pressure > 25 mmHg on medication, or according to investigator's judgment, at baseline (study eye) - Patient having a fellow eye with BCVA < 20/200 at baseline due to any causes (except when due to conditions that can lead to improved VA after surgery, e.g. cataract) - Patients who have been previously treated with brolucizumab in either eye, or who are currently receiving brolucizumab treatment in the fellow eye - Patients who have been treated with aflibercept longer than 24 months. - Previous use of intraocular or periocular steroids within the 6-months prior to baseline (study eye) - Macular laser photocoagulation (focal/grid) or photodynamic therapy (PDT) at any time prior to baseline and peripheral laser photocoagulation within 3 months prior to baseline (study eye) - Intraocular surgery within 3 months prior to baseline (except cataract; study eye) Vitreoretinal surgery at any time prior to baseline (study eye) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion (%) of patients switched from aflibercept 2 mg to brolucizumab 6mg that were able to successfully extend their dosing interval at week 52 without incurring disease activity after switching | To evaluate if Neovascular Age-related Macular Degeneration (nAMD) patients can extend treatment intervals after switching from 2mg aflibercept to 6mg brolucizumab, while maintaining treatment effectiveness | 104 weeks | |
Secondary | Mean maximum interval (number of weeks) of patients at week 104 | To evaluate dosing intervals and durability of brolucizumab 6mg used in a Treat and Extend regimen after switching from aflibercept 2mg | Up to 104 weeks | |
Secondary | The % of patients switched from aflibercept 2 mg to brolucizumab 6mg that were able to extend their dosing interval at week 104 | To evaluate dosing intervals and durability of brolucizumab 6mg used in a Treat and Extend regimen after switching from aflibercept 2mg | up to 104 weeks | |
Secondary | The % of patients switched from aflibercept 2 mg to brolucizumab 6mg that were able to maintain or extend their dosing interval at week 52 and 104 | To evaluate dosing intervals and durability of brolucizumab 6mg used in a Treat and Extend regimen after switching from aflibercept 2mg | up to 104 weeks | |
Secondary | Mean interval (number of weeks) of patients after switch reached at any given time point at week 52 and 104 | To evaluate dosing intervals and durability of brolucizumab 6mg used in a Treat and Extend regimen after switching from aflibercept 2mg | up to 104 weeks | |
Secondary | Mean change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (EDTRS letters) from baseline to week 52, and 104 | To evaluate changes in visual outcomes with brolucizumab after switching from aflibercept throughout the study in comparison to baseline assessments. | up to 104 weeks | |
Secondary | The % of patients with a change in BCVA (EDTRS letters) of 5, 10, 15 letters or more from baseline to week 52, and 104 | To evaluate changes in visual outcomes with brolucizumab after switching from aflibercept throughout the study in comparison to baseline assessments | up to 104 weeks | |
Secondary | The % of patients with any intraretinal fluid (IRF) and/or subretinal fluid (SRF) at baseline, weeks 52, and 104 | To evaluate changes of anatomical outcomes with brolucizumab after switching from aflibercept throughout the study in comparison to baseline assessments. | up to 104 weeks | |
Secondary | Incidence of ocular (e.g., intraocular infection) and non-ocular adverse events, vital signs up to week 52, and 104 | To evaluate safety and tolerability of treat and extend brolucizumab 6mg dosing | up to 104 weeks | |
Secondary | Mean change from baseline in central subfield foveal thickness (CSFT) | To evaluate changes of anatomical outcomes with brolucizumab after switching from aflibercept throughout the study in comparison to baseline assessments. | at weeks 52, 104 | |
Secondary | The % of patients with pigment epithelial detachment (PED) | To evaluate changes of anatomical outcomes with brolucizumab after switching from aflibercept throughout the study in comparison to baseline assessments. | at baseline, weeks 52, 104 |
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