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

Sponsor

Ivantis, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03065036

Collaborator

(none)

120

Enrollment

Locations

Arms

47.1

Actual Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma	Drug: prestudy topical glaucoma medications	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Vienna	Vienna		Austria	A-1090
2	Aurelios Augenzentrum	Recklinghausen	Erlbruch	Germany
3		Berlin		Germany	10559
4	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik	Mainz		Germany	55131
5		Tijuana	Baja California	Mexico

Sponsors and Collaborators

Ivantis, Inc.

Investigators

Principal Investigator: Prof. Dr. Manfred Tetz, MD, Augentagesklinik Spreebogen Berlin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ivantis, Inc.

ClinicalTrials.gov Identifier:

NCT03065036

Other Study ID Numbers:

CP-09-001
HYDRUS I

First Posted:

Feb 27, 2017

Last Update Posted:

Feb 4, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Ivantis, Inc.

Primary Open Angle Glaucoma

POAG

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Study Results

No Results Posted as of Feb 4, 2019