A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration

Korábbi kezelés

• History of stroke or myocardial infarction during the 6-month period prior to Baseline/Day 1, any current clinically significant arrhythmias, or any advanced cardiac or severe pulmonary hypertension

Más betegség

• History or current diagnosis of ECG abnormalities indicating significant safety risk, such as clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia and clinically significant second or third degree atrioventricular block (AV block) without a pacemaker.
• History of end stage kidney disease requiring dialysis or renal transplant
• History of malignancy of any organ system
• History of solid organ or bone marrow transplantation
• History of recurrent meningitis or history of meningococcal infections despite vaccination
• History of immunodeficiency diseases, including a positive Human Immunodeficiency Virus test result at Screening
• Active Hepatitis B (HBV) or Hepatitis C (HCV) infection
• History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes or clinically relevant sensitivity to fluorescein dye as assessed by the Investigator.

Laborértékek

• History of familial long QT syndrome or known family history of Torsades de Pointes
• Participants who have current active TB as evidenced by clinical, radiographic and laboratory tests.

Egyéb

• Evidence of cRORA or exMNV in the study eye based on multimodal imaging as determined by the central reading center.

• Male or female participants ≥ 50 years of age
• Diagnosis of early or intermediate age-related macular degeneration (AMD) in the study eye as determined by the investigator on fundus examination
• Study eye (early/intermediate AMD eye) must have at least one high risk optical coherence tomography (OCT) feature (as defined by a central reading center).
• Diagnosis of neovascular AMD (nAMD) in the fellow eye as determined by the investigator.
• Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection are required prior to the start of the treatment with LNP023.
• If not received previously, vaccination against Haemophilius influenzae infection should be given, if available and according to local regulations.