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

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Drug: prestudy topical glaucoma medications

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • University Medical Center Vienna
• Germany
  • Berlin, Germany, 10559
  • Mainz, Germany, 55131
    • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik
  • Erlbruch
    • Recklinghausen, Erlbruch, Germany
      • Aurelios Augenzentrum
• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrus Aqueous Implant; Hydrus implanted into Schlemm's Canal.	Drug: prestudy topical glaucoma medications; Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.
Other: IOL placement and Hydrus implant; Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal	Drug: prestudy topical glaucoma medications; Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IOP of study eye between each randomized group	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.	Baseline & One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ivantis, Inc.
• Investigators: Principal Investigator: Prof. Dr. Manfred Tetz, MD, Augentagesklinik Spreebogen Berlin

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 29, 2012
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: POAG; Primary Open Angle Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: CP-09-001; HYDRUS I (Other Identifier: Germany: Federal Institute for Drugs and Medical Devices)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO