NCT02307682

Efficacy and Safety of RTH258 Versus Aflibercept - Study 1

A Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 Versus Aflibercept in Subjects With Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,775 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.

Detailed description

Subjects were randomized to brolucizumab 3 mg, brolucizumab 6 mg,and aflibercept 2 mg in a 1:1:1 ratio. Subjects in all treatment arms received 3 monthly loading doses (Day 0, Week 4 and Week 8), followed by a maintenance regimen, until the end of the study (Week 96/Exit). All subjects attended pre-specified visits every 4 weeks. Subjects in the brolucizumab 3 mg and brolucizumab 6 mg arms followed a q12w/q8w maintenance regimen. Within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). If disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). Once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study. Subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study. Results reported up to Week 48 are based on the database locked for the primary analysis at Week 48. Results reported after Week 48 are based on the database locked at the end of study (final analysis).

Conditions

• Neovascular Age-Related Macular Degeneration
• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Brolucizumab ophthalmic solution	Ophthalmic solution for IVT injection
DRUG	Aflibercept ophthalmic solution	Ophthalmic solution for IVT injection

Timeline

• Start date: 2014-12-08
• Primary completion: 2017-04-22
• Completion: 2018-03-28
• First posted: 2014-12-04
• Last updated: 2025-01-16
• Results posted: 2019-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study