Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD

Completed · Phase 3

Conditions studied: Age-Related Macular Degeneration, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases

In brief

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).

Key facts

Study ID

NCT03954626

Run by

Novartis Pharmaceuticals

People needed

14

Starts

2019-06-07

Expected to finish

2019-07-31

Last updated by the study team

2021-01-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Abilene, Texas, United States
• Novartis Investigative Site — Arecibo, Puerto Rico

Full record on ClinicalTrials.gov

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