Loading clinical trials...

ACTIVE_NOT_RECRUITINGPHASE2

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

A Randomized, Participant and Investigator Masked, Placebo-controlled, Multicenter, Proof-of-concept Study to Assess the Safety and Efficacy of LNP023 (Iptacopan) in Patients With Early and Intermediate Age-related Macular Degeneration

NCT05230537•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

50 - 100 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (28)

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

Key Dates

Start Date

February 17, 2022

Primary Completion Date

October 1, 2026

Completion Date

October 2, 2026

Last Updated

July 3, 2025

Enrollment

170

ACTUAL participants

Conditions

Age-Related Macular Degeneration

Interventions

Iptacopan (LNP023)

DRUG

Placebo

DRUG

Direct Discrimination of Quantum States by the Human Eye

NCT05913063

Age-Related Macular Degeneration

View study

RECRUITINGPHASE2

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

NCT06990269

Geographic Atrophy Secondary to Age-related Macular Degeneration

View study

RECRUITINGPHASE4

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Direct Discrimination of Quantum States by the Human Eye

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)