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

Part of paid clinical trials in Fullerton, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05230537
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 17, 2022
Status verified
Jul 2025
Primary completion
Oct 1, 2026
Completion
Oct 2, 2026

Study Design

Enrollment
170 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Iptacopan (LNP023)
    Iptacopan (LNP023) oral use capsules
  • Placebo Comparator: Placebo
    Placebo matched to study drug, oral use capsules

Primary Outcome Measure

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 [ Time Frame: Baseline/Day 1 through Month 24 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Retina Consultants of Orange CountyFullertonCalifornia92835-
Salehi Retina InstituteHuntington BeachCalifornia92647-
Martel Eye Medical GroupRancho CordovaCalifornia95670-
Retinal Consultants Medical Group IncSacramentoCalifornia95841-
California Retina ConsultantsSanta BarbaraCalifornia93103-
Southwest Retina Research CenterDurangoColorado81303-
Advanced Research LLCDeerfield BeachFlorida33064-
Retina Center Of South FloridaDelray BeachFlorida33484-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-
Midwest Eye InstituteIndianapolisIndiana46280-
Retina Associates New OrleansNew OrleansLouisiana70115 8139-
Retina Care CenterBaltimoreMaryland21209-
Opthamalic Consultants of BostonBostonMassachusetts02114-
Envision Ocular LLCBloomfieldNew Jersey07003-
Duke Eye CenterDurhamNorth Carolina27705-
Retina Northwest PCPortlandOregon97210-
Charles Retina InstituteGermantownTennessee38138-
Austin Research Center for RetinaAustinTexas78793-
Retina Consultants TX Rsrch CtrBellaireTexas77401-
Retina FoundationDallasTexas75231-
Texas Retina AssociatesFort WorthTexas76104-
Retina Consultants of Houston PAHoustonTexas77030-

Find similar trials in Fullerton, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina Consultants of Orange County· Fullerton, CASalehi Retina Institute· Huntington Beach, CAMartel Eye Medical Group· Rancho Cordova, CARetinal Consultants Medical Group Inc· Sacramento, CACalifornia Retina Consultants· Santa Barbara, CASouthwest Retina Research Center· Durango, CO

Related Studies