NCT02507388

Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration

A Randomized, Double Masked, Three Dose Safety and Pharmacokinetic Study of RTH258 Following Intravitreal (IVT) Injection in Subjects With Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2 different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when administered at 4-week intervals for a total of 3 intravitreal injections in subjects with neovascular age-related macular degeneration (AMD).

Detailed description

This study has 2 arms with a 1:1 randomization. Randomization will be stratified by Japanese ethnicity. Half of the subjects in each arm will be of Japanese ethnicity. The other half of the subjects in each arm will be non-Japanese. Subjects in both arms will have visits at Screening, Day 0 (Baseline), Day 1 (24 hours post first injection), Day 3, Day 14, Day 21, Day 28, Day 56, Day 57 (24 hours post the injection on Day 56) and Day 84.

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Brolucizumab 3 mg/50 μL	Administered as an intravitreal injection
DRUG	Brolucizumab 6 mg/50 μL	Administered as an intravitreal injection

Timeline

• Start date: 2015-08-24
• Primary completion: 2016-09-06
• Completion: 2016-09-06
• First posted: 2015-07-23
• Last updated: 2018-07-02
• Results posted: 2017-09-29

Regulatory

• FDA-regulated drug study