Study of ANX007 in Participants With Primary Open-angle Glaucoma

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04188015
Study type	Interventional
Source	Annexon, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	July 25, 2018
Completion date	June 3, 2019

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