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

Primary Open Angle Glaucoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065036
• Other study ID #: CP-09-001
• Secondary ID: HYDRUS I
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2010
• Est. completion date: February 2014

Study information

• Verified date: January 2019
• Source: Ivantis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

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

Locations

Country	Name	City	State
Austria	University Medical Center Vienna	Vienna
Germany	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik	Mainz
Germany	Aurelios Augenzentrum	Recklinghausen	Erlbruch

Sponsors (1)

Lead Sponsor	Collaborator
Ivantis, Inc.

Countries where clinical trial is conducted

Austria,  Germany,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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