Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 1614 for:    glaucoma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03065036
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ivantis, Inc.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : March 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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.

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.




Primary Outcome Measures :
  1. Change in IOP of study eye between each randomized group [ Time Frame: 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 :
  1. Change in glaucoma medications [ Time Frame: Baseline & One year ]
    Calculate the change in the number of glaucoma medications from baseline (pre-operative) visit to the 12-month post-operative visit.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065036


Locations
Layout table for location information
Austria
University Medical Center Vienna
Vienna, Austria, A-1090
Germany
Aurelios Augenzentrum
Recklinghausen, Erlbruch, Germany
Berlin, Germany, 10559
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik
Mainz, Germany, 55131
Mexico
Tijuana, Baja California, Mexico
Sponsors and Collaborators
Ivantis, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Prof. Dr. Manfred Tetz, MD Augentagesklinik Spreebogen Berlin

Layout table for additonal information
Responsible Party: Ivantis, Inc.
ClinicalTrials.gov Identifier: NCT03065036     History of Changes
Other Study ID Numbers: CP-09-001
HYDRUS I ( Other Identifier: Germany: Federal Institute for Drugs and Medical Devices )
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ivantis, Inc.:
Primary Open Angle Glaucoma
POAG

Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases