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Clinical Trials in the UK / NCT05230537
Active, not recruiting Phase 2

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

NCT05230537 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2022-02-17
Last updated
2025-07-03

Condition(s) studied

Age-Related Macular Degeneration

Investigational drug(s) / intervention(s)

Iptacopan (LNP023)Placebo

Iptacopan (LNP023): oral capsules

Placebo: oral capsules

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Retina Consultants of Orange County Fullerton California
Salehi Retina Institute Huntington Beach California
Martel Eye Medical Group Rancho Cordova California
Retinal Consultants Medical Group Inc Sacramento California
California Retina Consultants Santa Barbara California
Southwest Retina Research Center Durango Colorado
Advanced Research LLC Deerfield Beach Florida
Retina Center Of South Florida Delray Beach Florida
Retina Vitreous Associates of Florida St. Petersburg Florida
Midwest Eye Institute Indianapolis Indiana
Retina Associates New Orleans New Orleans Louisiana
Retina Care Center Baltimore Maryland
Opthamalic Consultants of Boston Boston Massachusetts
Envision Ocular LLC Bloomfield New Jersey
Duke Eye Center Durham North Carolina
Retina Northwest PC Portland Oregon
Charles Retina Institute Germantown Tennessee
Austin Research Center for Retina Austin Texas
Retina Consultants TX Rsrch Ctr Bellaire Texas
Retina Foundation Dallas Texas
Texas Retina Associates Fort Worth Texas
Retina Consultants of Houston PA Houston Texas
Novartis Investigative Site Harbin Heilongjiang
Novartis Investigative Site Tianjin Tianjin Municipality
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

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05230537 on ClinicalTrials.gov ↗ ← All trials in the UK