study to collect safety and ecg data on brolucizumab 6 mg intravitreal treatment in patients with wet amd

Conditions: Age-Related Macular Degeneration; Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

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).

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.

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 \ 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

Keywords: amd, namd, wet amd, rth258, brolucizumab, ecg, open-label