Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full description
This is a single-arm, open-label, multicenter study that collected ECG data after a single IVT injection of brolucizumab 6 mg in patients with nAMD. Triplicate 12-lead ECG recording was performed at screening to determine eligibility. A second triplicate 12-lead ECG recording was collected approximately 2h prior to the brolucizumab IVT injection on Day 1. Holter ECG recording started approximately 1 h prior to the brolucizumab IVT injection and ended approximately 48h after the IVT injection. A third triplicate 12-lead ECG recording was performed after the conclusion of Holter monitoring on Day 3.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
14 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal