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

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.

Conditions

Age-Related Macular Degeneration

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Age-Related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Fullerton

Retina Consultants of Orange County, Fullerton, California, United States, 92835

Huntington Beach

Salehi Retina Institute, Huntington Beach, California, United States, 92647

Rancho Cordova

Martel Eye Medical Group, Rancho Cordova, California, United States, 95670

Sacramento

Retinal Consultants Medical Group, Inc, Sacramento, California, United States, 95841

Santa Barbara

California Retina Consultants ., Santa Barbara, California, United States, 93103

Durango

Southwest Retina Research Center, Durango, Colorado, United States, 81303

Deerfield Beach

Advanced Research LLC Research, Deerfield Beach, Florida, United States, 33064

Deerfield Beach

Advanced Research LLC, Deerfield Beach, Florida, United States, 33064

Delray Beach

Retina Center Of South Florida, Delray Beach, Florida, United States, 33484

Saint Petersburg

Retina Vitreous Associates of Florida, Saint Petersburg, Florida, United States, 33711

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2026-10-12