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

NCT ID: NCT03065036

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-02-28

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.

Conditions

Primary Open Angle Glaucoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydrus Aqueous Implant

Hydrus implanted into Schlemm's Canal.

Group Type: EXPERIMENTAL

prestudy topical glaucoma medications

Intervention Type: DRUG

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

IOL placement and Hydrus implant

Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal

Group Type: OTHER

prestudy topical glaucoma medications

Intervention Type: DRUG

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

Interventions

prestudy topical glaucoma medications

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ivantis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Dr. Manfred Tetz, MD

Role: PRINCIPAL_INVESTIGATOR

Augentagesklinik Spreebogen Berlin

Locations

University Medical Center Vienna

Vienna, , Austria

Aurelios Augenzentrum

Recklinghausen, Erlbruch, Germany

Berlin, , Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik

Mainz, , Germany

Tijuana, Estado de Baja California, Mexico

Countries

Austria; Germany; Mexico

Other Identifiers

HYDRUS I

Identifier Type: OTHER

Identifier Source: secondary_id

CP-09-001

Identifier Type: -

Identifier Source: org_study_id