Study Description
The purpose of this study is to assess the effect of Iptacopan to prevent conversion of
early or intermediate age-related macular degeneration (AMD) eyes to new incomplete
retinal pigment epithelium and outer retinal atrophy (iRORA) or late AMD. This is a multicenter, randomized, participant and investigator masked, placebo
controlled, proof-of-concept study to assess the safety and efficacy of Iptacopan
(LNP023) in participants with early to intermediate age-related macular degeneration in
one eye and neovascular age-related macular degeneration in the other eye. All enrolled
participants must have early/intermediate AMD in one eye, with at least one high risk
optical coherence tomography (OCT) feature (study eye) and neovascular AMD in the other
eye (fellow eye).
Participants who meet all of the eligibility criteria will be randomized at the
Baseline/Day 1 visit in a 1:1 ratio into one of two treatment arms:
- Iptacopan (LNP023) oral capsules
- Placebo oral capsules Approximately 146 participants (73 per arm) will be treated
worldwide.
Interventions
Iptacopan (LNP023)
Placebo
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 familial long QT syndrome or known family history of Torsades de Pointes
- 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
- 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.
- Evidence of cRORA or exMNV in the study eye based on multimodal imaging as
determined by the central reading center.
- Participants who have current active TB as evidenced by clinical, radiographic and
laboratory tests.
Study Location
Novartis Investigative Site
Recruiting
Gloucester,Gl1 3nn,United Kingdom
Worldwide Contacts
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