Status:
ACTIVE_NOT_RECRUITING
A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50-100 years
Phase:
PHASE2
Brief 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 a...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 2 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT05230537
Start Date
February 17 2022
End Date
October 2 2026
Last Update
July 3 2025
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Retina Consultants of Orange County
Fullerton, California, United States, 92835
2
Salehi Retina Institute
Huntington Beach, California, United States, 92647
3
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
4
Retinal Consultants Medical Group Inc
Sacramento, California, United States, 95841