NCT04188015

Study of ANX007 in Participants With Primary Open-angle Glaucoma

A Phase 1b, Randomized, Double-masked, Sham-controlled Study of ANX007 Administered as Intravitreal Injections to Assess Safety and Tolerability in Participants With Primary Open-angle Glaucoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Annexon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a double-masked, randomized, sham-controlled study evaluating two dose levels of ANX007 vs sham, administered as repeat Intravitreal (IVT) injections in patients with Primary Open-angle Glaucoma.

Detailed description

This is a phase 1b, double-masked, sham-controlled study evaluating 2 dose levels of ANX007 administered as 2 IVT injections separated by 4 weeks. Approximately 15-29 subjects will be enrolled. An interim analysis of the initial set of 15 participants may be conducted. Based on this analysis, an additional 10-14 participants may be enrolled at a 1:1 ratio to receive one of the two dose levels. The primary objective is to evaluate the safety and tolerability of repeat IVT injections of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the anterior chamber fluid pharmacokinetics (PK) of ANX007, PD effect of ANX007 on anterior chamber fluid C1q activity, and immunogenicity. An exploratory objective will evaluate ocular PD effect of ANX007.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
BIOLOGICAL	2.5mg ANX007	A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
BIOLOGICAL	5.0mg ANX007	A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
OTHER	Sham Procedure	The sham injection is preformed by applying pressure to the eye at the location of a typical IVT injection using the blunt end of a syringe without a needle.

Timeline

• Start date: 2018-07-25
• Primary completion: 2019-06-03
• Completion: 2019-06-03
• First posted: 2019-12-05
• Last updated: 2020-08-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study