NCT05230537

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Iptacopan (LNP023)	oral capsules
DRUG	Placebo	oral capsules

Timeline

• Start date: 2022-02-17
• Primary completion: 2026-10-01
• Completion: 2026-10-02
• First posted: 2022-02-09
• Last updated: 2025-07-03

Locations

28 sites across 4 countries: United States, China, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study