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

Phase 1

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Drug: prestudy topical glaucoma medications

• Registration Number: NCT03065036
• Lead Sponsor: Ivantis, Inc.

Brief 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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2012-02-29
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Study First Submitted QC: 2017-02-22
• Study First Posted: 2017-02-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Elevated intraocular pressure (IOP)
• Diagnosis of mild to advanced open-angle glaucoma
• Shaffer Grade III
• Mental capacity to cooperate when undergoing operative and postoperative examination
• 18 years of age or older
• Provide written informed consent
• Willing and able to return to scheduled follow-up examinations for 24-months

Exclusion Criteria

• Closed-angle and narrow-angle forms of glaucoma
• Secondary glaucomas
• Congenital or developmental glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IOL placement and Hydrus implant	prestudy topical glaucoma medications	Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal
Hydrus Aqueous Implant	prestudy topical glaucoma medications	Hydrus implanted into Schlemm's Canal.

Primary Outcome Measures

Name	Time	Method
Change in IOP of study eye between each randomized group	Baseline & One year	Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit.

Secondary Outcome Measures

Name	Time	Method
Change in glaucoma medications	Baseline & One year	Calculate the change in the number of glaucoma medications from baseline (pre-operative) visit to the 12-month post-operative visit.

Trial Locations

Locations (3)

University Medical Center Vienna; 🇦🇹 Vienna, Austria

Aurelios Augenzentrum; 🇩🇪 Recklinghausen, Erlbruch, Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik; 🇩🇪 Mainz, Germany