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• Status: Withdrawn
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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)