A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
NCT ID: NCT05230537
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
170 participants
INTERVENTIONAL
2022-02-17
2026-10-02
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Iptacopan (LNP023)
Iptacopan (LNP023) oral use capsules
Iptacopan (LNP023)
oral capsules
Placebo
Placebo matched to study drug, oral use capsules
Placebo
oral capsules
Interventions
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Iptacopan (LNP023)
oral capsules
Placebo
oral capsules
Eligibility Criteria
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Inclusion Criteria
* 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 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.
50 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Retina Consultants of Orange County
Fullerton, California, United States
Salehi Retina Institute
Huntington Beach, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
California Retina Consultants
Santa Barbara, California, United States
Southwest Retina Research Center
Durango, Colorado, United States
Advanced Research LLC
Deerfield Beach, Florida, United States
Retina Center Of South Florida
Delray Beach, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Retina Associates New Orleans
New Orleans, Louisiana, United States
Retina Care Center
Baltimore, Maryland, United States
Opthamalic Consultants of Boston
Boston, Massachusetts, United States
Envision Ocular LLC
Bloomfield, New Jersey, United States
Duke Eye Center
Durham, North Carolina, United States
Retina Northwest PC
Portland, Oregon, United States
Charles Retina Institute
Germantown, Tennessee, United States
Austin Research Center for Retina
Austin, Texas, United States
Retina Consultants TX Rsrch Ctr
Bellaire, Texas, United States
Retina Foundation
Dallas, Texas, United States
Texas Retina Associates
Fort Worth, Texas, United States
Retina Consultants of Houston PA
Houston, Texas, United States
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Tianjin, Tianjin Municipality, China
Novartis Investigative Site
Shanghai, , China
Emanuelli Research and Development Center LLC
Arecibo, , Puerto Rico
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Southampton, , United Kingdom
Countries
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References
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Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
Other Identifiers
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2021-001797-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLNP023E12201
Identifier Type: -
Identifier Source: org_study_id
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