A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration (NCT05230537) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
United States170 participantsStarted 2022-02-17
Plain-language 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.
Who can participate
Age range50 Years – 100 Years
SexALL
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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 or…
What they're measuring
1
Development of new incomplete retinal pigment epithelium & outer retinal atrophy or late age-related macular degeneration (AMD) in the early/intermediate AMD eye as determined by optical coherence tomography (OCT) & supported by multimodal imaging