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.
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 intermediate age-related macular degeneration in one eye and neovascular age-related macular degeneration in the other eye. All enrolled participants must have early/intermediate AMD in one eye, with at least one high risk optical coherence tomography (OCT) feature (study eye) and neovascular AMD in the other eye (fellow eye). Participants who meet all of the eligibility criteria will be randomized at the Baseline/Day 1 visit in a 1:1 ratio into one of two treatment arms: * Iptacopan (LNP023) oral capsules * Placebo oral capsules Approximately 146 participants (73 per arm) will be treated worldwide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
170
oral capsules
oral capsules
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
OCT and other imaging will be performed using spectral domain OCT or swept source OCT machines
Time frame: Baseline/Day 1 through Month 24
The incidence of ocular and non-ocular adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.
Time frame: Baseline/Day 1 through Month 24
Change in Early Treatment Diabetic Retinopathy Study (ETDRS) (Standard Luminance) best corrected visual acuity (BCVA) scores in the early/intermediate AMD eye
Best corrected visual acuity (BCVA) will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. The number of letters read correctly, for each eye, will be recorded. Participants at sites in some countries may conduct BCVA testing using numerical charts rather than letter charts.
Time frame: Baseline/Day 1 through Month 24
Change in ETDRS low luminance visual acuity (LLVA) scores in the early/intermediate AMD eye
ETDRS low luminance visual acuity (LLVA) scores will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. The number of letters read correctly, for each eye, will be recorded. Participants at sites in some countries may conduct BCVA testing using numerical charts rather than letter charts.
Time frame: Baseline/Day 1 through Month 24
Change in contrast sensitivity (CS) scores in the early/intermediate AMD eye
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Retina Consultants of Orange County
Fullerton, California, United States
Salehi Retina Institute
Huntington Beach, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
California Retina Consultants
Santa Barbara, California, United States
Southwest Retina Research Center
Durango, Colorado, United States
Advanced Research LLC
Deerfield Beach, Florida, United States
Retina Center Of South Florida
Delray Beach, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
...and 18 more locations
Pelli-Robson contrast sensitivity measurements will be performed using a Pelli-Robson contrast sensitivity wall chart and recording the number of correct letters read.
Time frame: Baseline/Day 1 through Month 24
Change in Standard luminance manifold contrast vision meter contrast sensitivity (MCVM-CS) scores in the early/intermediate AMD eye
MCVM contrast sensitivity measurements will be performed using an automated device that uses an adaptive algorithm to rapidly measure a contrast sensitivity function in 5-10 minutes.
Time frame: Baseline/Day 1 through Month 24
Pharmacokinetics - concentrations of LNP023 related to trough samples
Bioanalytical determination of plasma LNP023 concentrations related to trough samples using a LC-MS (mass spectrometry) method.
Time frame: Baseline/Day 1 through Month 24
Change in low luminance manifold contrast vision meter (MCVM) contrast sensitivity scores in the early/intermediate AMD eye
MCVM contrast sensitivity measurements will be performed using an automated device that uses an adaptive algorithm to rapidly measure a contrast sensitivity function in 5-10 minutes.
Time frame: Baseline/Day 1 through Month 24