A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
A Randomized, Participant and Investigator Masked, Placebo-controlled, Multicenter, Proof-of-concept Study to Assess the Safety and Efficacy of LNP023 (Iptacopan) in Patients With Early and Intermediate Age-related Macular Degeneration
ClinicalTrials.gov Identifier: NCT05230537
Novartis Reference Number: CLNP023E12201
Last Update: Feb 08, 2023
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
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.
Interventions
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:
Concomitant medical or ocular conditions which could compromise visual acuity, require planned medical or surgical intervention during the study period, preclude scheduled study visits, completion of the study, or safe administration of the investigational product, including intraocular surgery, cataract and vitreoretinal surgery in the study eye within 3 months prior to Baseline/Day 1 and the presence of significant media opacity, eye movement disorder (nystagmus), severe ptosis, extraocular motility restriction or head tremor.
History of clinically significant electrocardiogram (ECG) abnormalities, or any of the following ECG abnormalities at screening or Baseline/Day 1 visit:
QT interval corrected by Fridericia's formula (QTcF) >450 msec (males)
QTcF >460 msec (females)
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 kidney failure including end stage renal 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
Chronic infection with Hepatitis B or Hepatitis C.
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.
Study Locations
Contacts
Have a question?
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