Age-related Macular Degeneration (AMD)Phase 3PEREGRINENCT04697953
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)
A Phase 3 study testing brolucizumab in people with Age-related Macular Degeneration (AMD), run by Novartis Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- What is being tested?
- brolucizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2021to 31 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
About this study
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)
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.
Read the 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)
- Being tested
- brolucizumab
- Keywords
- neovascular age-related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brolucizumabDrug
Pre-filled Syringes for intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| brolucizumab 6mg | Experimental | Open label, brolucizumab 6mg, daily dosing, Treat \& Extend regimen by up to 2 week intervals. Dosing intervals as per previous therapy and treatment extension intervals Receives: Drug: brolucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 104 weeks
Secondary outcomes (10)
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
Measured: Up to 104 weeks
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
Measured: up to 104 weeks
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
Measured: up to 104 weeks
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
Measured: up to 104 weeks
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.
Measured: up to 104 weeks
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
Measured: up to 104 weeks
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.
Measured: up to 104 weeks
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
Measured: up to 104 weeks
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.
Measured: at weeks 52, 104
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.
Measured: at baseline, weeks 52, 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start31 May 2021 (estimated)
- Primary completion21 Jun 2021 (estimated)
- Study completion31 May 2025 (estimated)
Why it stopped: Study terminated - no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study design This study is a 104-week, single arm, open label, Ph IIIb multicenter study in Canadian nAMD patients. Neovascular AMD patients will be switched from aflibercept Q6-12W to brolucizumab at the same dosing interval at baseline. At the second visit the treating physician will conduct a disease activity assessment. If patient is stable, treatment will be extended by up to two (2) weeks using a Treat and Extend regimen interval. If the patient remains stable, the extension will also occur at next visits until maximum of Q20 Weeks.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697953
- Sponsor's protocol ID
- CRTH258ACA03
- Acronym
- PEREGRINE
- Status last verified
- Sep 2021
- First submitted
- 30 Nov 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04697953
- Acronym / sponsor ID
- PEREGRINE / CRTH258ACA03
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- neovascular age-related macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated - no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 May 2021 (estimated)
- Primary completion
- 21 Jun 2021 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.]).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study design This study is a 104-week, single arm, open label, Ph IIIb multicenter study in Canadian nAMD patients. Neovascular AMD patients will be switched from aflibercept Q6-12W to brolucizumab at the same dosing interval at baseline. At the second visit the treating physician will conduct a disease activity assessment. If patient is stable, treatment will be extended by up to two (2) weeks using a Treat and Extend regimen interval. If the patient remains stable, the extension will also occur at next visits until maximum of Q20 Weeks.
| Arm | Type | Receives |
|---|---|---|
| brolucizumab 6mg | Experimental | Drug: brolucizumabOpen label, brolucizumab 6mg, daily dosing, Treat \& Extend regimen by up to 2 week intervals. Dosing intervals as per previous therapy and treatment extension intervals |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brolucizumabPre-filled Syringes for intravitreal injection | Drug | brolucizumab 6mg |
Primary outcome
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
Time frame: 104 weeks
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
10 secondary outcomes
Mean maximum interval (number of weeks) of patients at week 104
Time frame: Up to 104 weeks
The % of patients switched from aflibercept 2 mg to brolucizumab 6mg that were able to extend their dosing interval at week 104
Time frame: up to 104 weeks
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
Time frame: up to 104 weeks
Mean interval (number of weeks) of patients after switch reached at any given time point at week 52 and 104
Time frame: up to 104 weeks
Mean change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (EDTRS letters) from baseline to week 52, and 104
Time frame: up to 104 weeks
The % of patients with a change in BCVA (EDTRS letters) of 5, 10, 15 letters or more from baseline to week 52, and 104
Time frame: up to 104 weeks
The % of patients with any intraretinal fluid (IRF) and/or subretinal fluid (SRF) at baseline, weeks 52, and 104
Time frame: up to 104 weeks
Incidence of ocular (e.g., intraocular infection) and non-ocular adverse events, vital signs up to week 52, and 104
Time frame: up to 104 weeks
Mean change from baseline in central subfield foveal thickness (CSFT)
Time frame: at weeks 52, 104
The % of patients with pigment epithelial detachment (PED)
Time frame: at baseline, weeks 52, 104
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing brolucizumab in people with Age-related Macular Degeneration (AMD), run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.