search
Back to results

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

Primary Purpose

Primary Open Angle Glaucoma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
prestudy topical glaucoma medications
Sponsored by
Ivantis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary Open Angle Glaucoma, POAG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Medical Center Vienna
  • Aurelios Augenzentrum
  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hydrus Aqueous Implant

IOL placement and Hydrus implant

Arm Description

Hydrus implanted into Schlemm's Canal.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 29, 2012
Last Updated
January 31, 2019
Sponsor
Ivantis, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03065036
Brief Title
Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG
Acronym
POAG
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivantis, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
Primary Open Angle Glaucoma, POAG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrus Aqueous Implant
Arm Type
Experimental
Arm Description
Hydrus implanted into Schlemm's Canal.
Arm Title
IOL placement and Hydrus implant
Arm Type
Other
Arm Description
Cataract Extraction with IOL placement and Hydrus implant into Schlemm's canal
Intervention Type
Drug
Intervention Name(s)
prestudy topical glaucoma medications
Intervention Description
Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.
Primary Outcome Measure Information:
Title
Change in IOP of study eye between each randomized group
Description
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.
Time Frame
Baseline & One year
Secondary Outcome Measure Information:
Title
Change in glaucoma medications
Description
Calculate the change in the number of glaucoma medications from baseline (pre-operative) visit to the 12-month post-operative visit.
Time Frame
Baseline & One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Manfred Tetz, MD
Organizational Affiliation
Augentagesklinik Spreebogen Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Vienna
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Aurelios Augenzentrum
City
Recklinghausen
State/Province
Erlbruch
Country
Germany
City
Berlin
ZIP/Postal Code
10559
Country
Germany
Facility Name
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Tijuana
State/Province
Baja California
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs