Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD
Condition: Age-Related Macular Degeneration; Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases
MeSH terms: Macular Degeneration; Eye Diseases; Retinal Diseases; Retinal Degeneration; Wet Macular Degeneration
Intervention: brolucuzumab 6 mg IVT
Intervention description: Single intravitreal injection (IVT) of brolucizumab 6 mg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single arm, multicenter
Masking: None (Open Label)
Masking description: Open label study
Enrollment: 14.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD, nAMD, wet AMD, RTH258, brolucizumab, ECG, open-label

Summary:

      The purpose of this study was to collect ECG data after a single IVT injection of
      brolucizumab 6 mg in patients with neovascular age-related macular degeneration (nAMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent MUST be obtained prior to participation in the study

          -  Study eye is diagnosed with nAMD and deemed to be eligible for intravitreal injection
             at the discretion of the Investigator

        Exclusion Criteria:

          -  Concomitant conditions or ocular disorders in the study eye at screening which may
             cause safety concerns on the judgement of the investigator

          -  Any active intraocular or periocular or systemic infection or active intraocular
             inflammation at Baseline

          -  Treatment with any ocular intravitreal injection in the study eye within the past 7
             half lives prior to Baseline

          -  Intraocular surgery, prior long-acting therapeutic agent, or ocular drug release
             device implantation (approved or investigational) in the study eye any time during the
             past 3 months prior to Baseline

          -  Diagnosis of ECG abnormalities including:

          -  Clinically significant cardiac arrhythmias, e.g., atrial fibrillation, sustained
             ventricular tachycardia, and clinically significant second or third degree AV block
             without a pacemaker

          -  Familial long QT syndrome or known family history of Torsades de Pointes

          -  Resting heart rate < 50 or > 90 bpm at screening

          -  Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at screening

          -  Use of concomitant medications that are classified as known risk, conditional risk or
             possible risk to prolong QT/QTc interval within 7 half-lives prior to Baseline

          -  History of stroke (including transient ischemic attack, reversible ischemic
             neurological deficit, prolonged reversible ischemic neurological deficit) or
             myocardial infarction (ST or non-ST elevation myocardial infarction) at any time prior
             to baseline

          -  Chronic kidney disease as determined as a CrCL at screening of < 60 ml/min/1.73 m2 as
             determined by the MDRD formula

          -  Uncontrolled high blood pressure defined as a systolic value ≥ 140 mmHg or diastolic
             value ≥ 90 mmHg at screening or baseline

          -  Systemic anti-VEGF therapy during the 6-month period prior to baseline

          -  Electrolyte disturbances determined as out of normal range sodium, potassium or
             calcium serum concentrations at screening

          -  Concomitant intake of long-acting muscarinic antagonist (LAMA)/ long-acting beta
             adrenergic (LABA) combination therapy

          -  History of hypersensitivity to any of the study drugs or its excipients or to drugs of
             similar classes as assessed by the investigator

          -  Use of systemic or ocular (including intravitreal) investigational drugs within 7
             half-lives of baseline, (or within 30 days/until the expected pharmacodynamic effect
             has returned to baseline), whichever is longer or longer if required by local
             regulations (observational clinical studies solely involving over-the-counter
             vitamins, supplements, or diets are not exclusionary)

          -  Pregnant or nursing (lactating) women