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)

NCT04697953 | Withdrawn Phase 3

• 1 other identifier: CRTH258ACA03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Age-related Macular Degeneration (AMD)

Keywords

neovascular age-related macular degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mean maximum interval (number of weeks) of patients at week 104

  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

  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

  up to 104 weeks

• Mean interval (number of weeks) of patients after switch reached at any given time point at week 52 and 104

  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

  up to 104 weeks

Study Arms (1)

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

Drug: brolucizumab

Interventions

brolucizumab DRUG

Pre-filled Syringes for intravitreal injection

brolucizumab 6mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Macular Degeneration

Interventions

brolucizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 6, 2021
• Study Start: May 31, 2021
• Primary Completion: June 21, 2021
• Study Completion: May 31, 2025
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share