Age-Related Macular Degeneration Clinical Trial
Official title:
A Single-Arm, Open-Label, Multicenter, Phase IIIb Study to Collect Safety and Electrocardiogram Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Neovascular Age-Related Macular Degeneration
Verified date | August 2020 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 14 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 9, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Novartis Investigative Site | Arecibo | |
United States | Novartis Investigative Site | Abilene | Texas |
United States | Novartis Investigative Site | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of Clinically Relevant Treatment Emergent ECG Changes After Intravitreal Injection of Brolucizumab 6 mg in Patients With nAMD | Incidence between 20 and 24 h post-injection of clinically relevant treatment emergent changes in heart rate (HR), pulse rate (PR), QRS, and QTc (heart rate corrected QT using Fridericia's formula, QTcF) interval (ms). This is a composite endpoint capturing all 4 parameters and 3 time-points in one Outcome Measure. | Baseline, Hour 20, Hour 22, Hour 24 |
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