A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT05230537

Run by

Novartis Pharmaceuticals

People needed

170

Starts

2022-02-17

Expected to finish

2026-10-02

Last updated by the study team

2025-07-03

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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