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
Tianjin,Tianjin,300020,China
Novartis Investigative Site
Recruiting
Harbin City,Heilongjiang,150000,China
Novartis Investigative Site
Recruiting
Shanghai,200080,China
Emanuelli Research and Development Center LLC
Recruiting
Arecibo,Mileiry Mendez (+1 787 879 7722) email: [email protected] -- Andres Emanuelli Anzallota,00612,Puerto Rico
Novartis Investigative Site
Recruiting
Southampton,SO16 6YD,United Kingdom
Novartis Investigative Site
Recruiting
London,SE5 9RS,United Kingdom
Salehi Retina Institute
Recruiting
Huntington Beach,Yvonne Ramirez (657-227-9496) email: [email protected] -- Hani Salehi-Had,92647 - California,United States
Envision Ocular LLC
Recruiting
Bloomfield,Victoriana Sacco (973-707-5632) email: [email protected] -- Patrick Higgins,07003 - New Jersey,United States
Retina Consultants of Orange County
Recruiting
Fullerton,Bianka Carrillo (714-738-4620) email: [email protected] -- Ash Pirouz,92835 - California,United States
Advanced Research LLC
Recruiting
Coral Springs,Isabella Alvarez (954-204-0052) email: [email protected] -- Shailesh Gupta,33067 - Florida,United States
Southwest Retina Research Center
Recruiting
Durango,Caroline Tom email: [email protected] -- Sara Haug,81303 - Colorado,United States
Martel Eye Medical Group
Recruiting
Rancho Cordova,Liliya Golas,95670 - California,United States
Retina Consultants TX Rsrch Ctr
Recruiting
Bellaire,Jaclyn Henderson (713-524-3434) email: [email protected] -- David M Brown,77401 - Texas,United States
Austin Research Center for Retina .
Recruiting
Austin,(832-428-8991) -- Chirag Jhaveri,78793 - Texas,United States
Opthamalic Consultants of Boston
Recruiting
Boston,Charles McMahon (617-314-2636) email: [email protected] -- Jeffrey S Heier,02114 - Massachusetts,United States
Texas Retina Associates
Recruiting
Fort Worth,Lourdes Martinez (817-334-0882) email: [email protected] -- Patrick Williams,76104 - Texas,United States
Midwest Eye Institute Research
Recruiting
Indianapolis,Heidy Villanueva email: [email protected] -- Neil Finnen,46280 - Indiana,United States
Retina Foundation
Recruiting
Dallas,Katherine Juroch (+1 214 363 3911#145) email: [email protected] -- Karl Csaky,75231 - Texas,United States
California Retina Consultants .
Recruiting
Santa Barbara,Isabel Martinez email: [email protected] -- Dante Pieramici,93103 - California,United States
Retina Associates New Orleans .
Recruiting
New Orleans,Amanda Byers email: [email protected] -- Gwen Cousins,70115-8139 - Louisiana,United States
Vitreous Retina Macula Consultants Research
Recruiting
New York,Christelle Scrubb email: [email protected] -- Irene Barbazetto,10022 - New York,United States
Retina Northwest PC .
Recruiting
Portland,Cynthia Larsen (503-274-2121) email: [email protected] -- Paul Tlucek,97210 - Oregon,United States
Charles Retina Institute
Recruiting
Germantown,Kendall Beasley (901-767-4499) email: [email protected] -- Stephen Huddleston,38138 - Tennessee,United States
Retina Care Center Research
Recruiting
Baltimore,Charles Crouse email: [email protected] -- Eric Suan,21209 - Maryland,United States
Retina Vitreous Associates of Florida
Recruiting
Saint Petersburg,Megan Gross (727-323-0077) email: [email protected] -- David Eichenbaum,33711 - Florida,United States
Duke Eye Center Research
Recruiting
Durham,Natalia Cook email: [email protected] -- Eleonora Georgeta Lad,27705 - North Carolina,United States
Retina Center Of South Florida
Recruiting
Delray Beach,Kasha Phillips email: [email protected] -- Robert Raden,33484 - Florida,United States
Retinal Consultants Medical Group, Inc
Recruiting
Sacramento,Christopher Liu (916-339-3655) email: [email protected] -- Margaret Chang,95841 - California,United States
Retina Consultants of Houston PA .
Recruiting
Houston,Sandra Menjivar (936-273-6620) email: [email protected] -- Charles C Wykoff,77030 - Texas,United States
Worldwide Contacts
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