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

ClinicalTrials.gov Identifier: NCT05230537

Novartis Reference Number: CLNP023E12201

Last Update: Sep 22, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study 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.

Condition 
Age-Related Macular Degeneration
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Feb 17, 2022
Completion date 
Jan 07, 2027
Gender 
All
Age(s)
50 Years and older (Adult, Older Adult)

Interventions

Drug
Iptacopan (LNP023)
oral capsules
Drug
Placebo
oral capsules

Eligibility Criteria

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:

Concomitant medical or ocular conditions which could compromise visual acuity, require planned medical or surgical intervention during the study period, preclude scheduled study visits, completion of the study, or safe administration of the investigational product, including intraocular surgery, cataract and vitreoretinal surgery in the study eye within 3 months prior to Baseline/Day 1 and the presence of significant media opacity, eye movement disorder (nystagmus), severe ptosis, extraocular motility restriction or head tremor.

History of clinically significant electrocardiogram (ECG) abnormalities, or any of the following ECG abnormalities at screening or Baseline/Day 1 visit:

QT interval corrected by Fridericia's formula (QTcF) >450 msec (males)
QTcF >460 msec (females)
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 kidney failure including end stage renal 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
Chronic infection with Hepatitis B or Hepatitis C.
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.

Study Locations

United States
Novartis Investigative Site
Recruiting
Sacramento, 95841
California
United States
Novartis Investigative Site
Recruiting
Coral Springs, 33067
Florida
United States
Novartis Investigative Site
Recruiting
Saint Petersburg, 33711
Florida
United States
Novartis Investigative Site
Recruiting
Indianapolis, 46280
Indiana
United States
Novartis Investigative Site
Recruiting
Kingston, 95403
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Austin, 78793
Texas
United States
Novartis Investigative Site
Recruiting
Dallas, 75231
Texas
United States
Novartis Investigative Site
Recruiting
Fort Worth, 76104
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77030
Texas
United States
Puerto Rico
Novartis Investigative Site
Recruiting
Arecibo, 00612
-
Puerto Rico

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]