NCT03065036

Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG

A Prospective, Multi-Center Evaluation of the Hydrus Aqueous Implant (Standard and Low-Profile) for Lowering Intraocular Pressure (IOP) in Subjects With Mild to Advanced Primary Open Angle Glaucoma (POAG) With or Without a Cataract

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Ivantis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.

Detailed description

This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens. Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus. Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	prestudy topical glaucoma medications	Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-11-01
• Completion: 2014-02-01
• First posted: 2017-02-27
• Last updated: 2019-02-04

Locations

5 sites across 3 countries: Austria, Germany, Mexico