ACTIVE_NOT_RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-17

Study Completion:2026-10-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05230537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

Retina Consultants of Orange County

Fullerton, California, 92835

United States

Salehi Retina Institute

Huntington Beach, California, 92647

United States

Martel Eye Medical Group

Rancho Cordova, California, 95670

United States

Retinal Consultants Medical Group Inc

Sacramento, California, 95841

United States

California Retina Consultants

Santa Barbara, California, 93103

United States

Southwest Retina Research Center

Durango, Colorado, 81303

United States

Advanced Research LLC

Deerfield Beach, Florida, 33064

United States

Retina Center Of South Florida

Delray Beach, Florida, 33484

United States

Retina Vitreous Associates of Florida

Saint Petersburg, Florida, 33711

United States

Midwest Eye Institute

Indianapolis, Indiana, 46280

United States

Retina Associates New Orleans

New Orleans, Louisiana, 70115 8139

United States

Retina Care Center

Baltimore, Maryland, 21209

United States

Opthamalic Consultants of Boston

Boston, Massachusetts, 02114

United States

Envision Ocular LLC

Bloomfield, New Jersey, 07003

United States

Duke Eye Center

Durham, North Carolina, 27705

United States

Retina Northwest PC

Portland, Oregon, 97210

United States

Charles Retina Institute

Germantown, Tennessee, 38138

United States

Austin Research Center for Retina

Austin, Texas, 78793

United States

Retina Consultants TX Rsrch Ctr

Bellaire, Texas, 77401

United States

Retina Foundation

Dallas, Texas, 75231

United States

Texas Retina Associates

Fort Worth, Texas, 76104

United States

Retina Consultants of Houston PA

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-17

Study Completion Date2026-10-02

Study Record Updates

Study Start Date2022-02-17

Study Completion Date2026-10-02

Terms related to this study

Keywords Provided by Researchers

Age-related macular degeneration
Macular degeneration
vision loss, macula damage
retina damage
dry macular degeneration
wet macular degeneration
AMD
Best Corrected Visual Acuity
Neovascular AMD
OCT

Additional Relevant MeSH Terms

Age-Related Macular Degeneration