Phase
Condition
Aging
Macular Degeneration
Geographic Atrophy
Treatment
Iptacopan (LNP023)
Placebo
Clinical Study ID
Ages 50-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants ≥ 50 years of age
Diagnosis of early or intermediate age-related macular degeneration (AMD) in thestudy eye as determined by the investigator on fundus examination
Study eye (early/intermediate AMD eye) must have at least one high risk opticalcoherence tomography (OCT) feature (as defined by a central reading center).
Diagnosis of neovascular AMD (nAMD) in the fellow eye as determined by theinvestigator.
Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infectionare required prior to the start of the treatment with LNP023.
If not received previously, vaccination against Haemophilius influenzae infectionshould be given, if available and according to local regulations.
Exclusion
Exclusion Criteria:
History or current diagnosis of ECG abnormalities indicating significant safetyrisk, such as clinically significant cardiac arrhythmias, e.g., sustainedventricular tachycardia and clinically significant second or third degreeatrioventricular 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 toBaseline/Day 1, any current clinically significant arrhythmias, or any advancedcardiac 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 despitevaccination
History of immunodeficiency diseases, including a positive Human ImmunodeficiencyVirus 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 drugsof similar chemical classes or clinically relevant sensitivity to fluorescein dye asassessed by the Investigator.
Evidence of cRORA or exMNV in the study eye based on multimodal imaging asdetermined by the central reading center.
Participants who have current active TB as evidenced by clinical, radiographic andlaboratory tests.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Harbin, Heilongjiang 150001
ChinaSite Not Available
Novartis Investigative Site
Harbin City, Heilongjiang 150000
ChinaSite Not Available
Novartis Investigative Site
Tianjin, Tianjin 300020
ChinaSite Not Available
Novartis Investigative Site
Shanghai, 200080
ChinaSite Not Available
Emanuelli Research and Development Center LLC
Arecibo, 00612
Puerto RicoSite Not Available
Novartis Investigative Site
Arecibo, 00612
Puerto RicoActive - Recruiting
Novartis Investigative Site
Gloucester, GL1 3NN
United KingdomSite Not Available
Novartis Investigative Site
London, SE5 9RS
United KingdomSite Not Available
Novartis Investigative Site
Southampton, SO16 6YD
United KingdomSite Not Available
Novartis Investigative Site
Fullerton, California 92835
United StatesActive - Recruiting
Retina Consultants of Orange County
Fullerton, California 92835
United StatesSite Not Available
Novartis Investigative Site
Huntington Beach, California 92647
United StatesActive - Recruiting
Salehi Retina Institute
Huntington Beach, California 92647
United StatesSite Not Available
Martel Eye Medical Group
Rancho Cordova, California 95670
United StatesSite Not Available
Novartis Investigative Site
Rancho Cordova, California 95670
United StatesActive - Recruiting
Novartis Investigative Site
Sacramento, California 95841
United StatesActive - Recruiting
Retinal Consultants Medical Group Inc
Sacramento, California 95841
United StatesSite Not Available
Retinal Consultants Medical Group, Inc
Sacramento, California 95841
United StatesSite Not Available
California Retina Consultants
Santa Barbara, California 93103
United StatesSite Not Available
California Retina Consultants .
Santa Barbara, California 93103
United StatesSite Not Available
Novartis Investigative Site
Durango, Colorado 81303
United StatesActive - Recruiting
Southwest Retina Research Center
Durango, Colorado 81303
United StatesSite Not Available
Advanced Research LLC
Coral Springs, Florida 33067
United StatesSite Not Available
Novartis Investigative Site
Coral Springs, Florida 33067
United StatesActive - Recruiting
Advanced Research LLC
Deerfield Beach, Florida 33064
United StatesSite Not Available
Advanced Research LLC Research
Deerfield Beach, Florida 33064
United StatesSite Not Available
Novartis Investigative Site
Delray Beach, Florida 33484
United StatesActive - Recruiting
Retina Center Of South Florida
Delray Beach, Florida 33484
United StatesSite Not Available
Novartis Investigative Site
Saint Petersburg, Florida 33711
United StatesActive - Recruiting
Retina Vitreous Associates of Florida
Saint Petersburg, Florida 33711
United StatesSite Not Available
Midwest Eye Institute
Indianapolis, Indiana 46280
United StatesSite Not Available
Midwest Eye Institute Research
Indianapolis, Indiana 46280
United StatesSite Not Available
Novartis Investigative Site
Indianapolis, Indiana 46280
United StatesActive - Recruiting
Novartis Investigative Site
New Orleans, Louisiana 70115-8139
United StatesActive - Recruiting
Retina Associates New Orleans
New Orleans, Louisiana 70115 8139
United StatesSite Not Available
Retina Associates New Orleans .
New Orleans, Louisiana 70115 8139
United StatesSite Not Available
Retina Care Center
Baltimore, Maryland 21209
United StatesSite Not Available
Retina Care Center Research
Baltimore, Maryland 21209
United StatesSite Not Available
Novartis Investigative Site
Boston, Massachusetts 02114
United StatesActive - Recruiting
Opthamalic Consultants of Boston
Boston, Massachusetts 02114
United StatesSite Not Available
Envision Ocular LLC
Bloomfield, New Jersey 07003
United StatesSite Not Available
Vitreous Retina Macula Consultants Research
New York, New York 10022
United StatesSite Not Available
Duke Eye Center
Durham, North Carolina 27705
United StatesSite Not Available
Duke Eye Center Research
Durham, North Carolina 27705
United StatesSite Not Available
Novartis Investigative Site
Portland, Oregon 97210
United StatesActive - Recruiting
Retina Northwest PC
Portland, Oregon 97210
United StatesSite Not Available
Retina Northwest PC .
Portland, Oregon 97210
United StatesSite Not Available
Novartis Investigative Site
Kingston, Pennsylvania 18704
United StatesSite Not Available
Charles Retina Institute
Germantown, Tennessee 38138
United StatesSite Not Available
Novartis Investigative Site
Germantown, Tennessee 38138
United StatesActive - Recruiting
Austin Research Center for Retina
Austin, Texas 78793
United StatesSite Not Available
Austin Research Center for Retina .
Austin, Texas 78793
United StatesSite Not Available
Novartis Investigative Site
Austin, Texas 78793
United StatesActive - Recruiting
Novartis Investigative Site
Bellaire, Texas 77401
United StatesActive - Recruiting
Retina Consultants TX Rsrch Ctr
Bellaire, Texas 77401
United StatesSite Not Available
Novartis Investigative Site
Dallas, Texas 75231
United StatesActive - Recruiting
Retina Foundation
Dallas, Texas 75231
United StatesSite Not Available
Novartis Investigative Site
Fort Worth, Texas 76104
United StatesActive - Recruiting
Texas Retina Associates
Fort Worth, Texas 76104
United StatesSite Not Available
Novartis Investigative Site
Houston, Texas 77030
United StatesActive - Recruiting
Retina Consultants of Houston PA
Houston, Texas 77030
United StatesSite Not Available
Retina Consultants of Houston PA .
Houston, Texas 77030
United StatesSite Not Available

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