A Prospective, Unmasked Evaluation of the iStent in Patie... | NCT00911924

Studies
A Prospective, Unmasked Evaluation of the iStent in Patients With Primary Open-Angle Glaucoma

NCT00911924

Sponsor

Glaukos Corporation

Status

Completed

Last Update Posted

May 20, 2015Estimated

Enrollment

112Actual

Phase

Phase 4

Conditions

Glaucoma
Eye Diseases
Glaucoma, Open-Angle

Interventions

iStent

Countries

Armenia
Austria
France
Germany
Italy
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Synergy Trial

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jun 1, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2015

Last Update Posted Date

May 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, unmasked, evaluation of the iStent in patients that have primary open-angle glaucoma (OAG). Stent implantation in one eye will be used for analysis, with medication added at 6 months, as required.

Detailed Description

One hundred patients will be enrolled in the study at up to 21 sites; follow-up is through 1 year.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iStent	Experimental		Device: iStent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iStent	Device	Glaukos iStent, medication	iStent	stent, trabecular micro-bypass stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IOP 18 mm Hg or less without medications		At 6 months
IOP 18 mm Hg or less with or without medications		12 months

Secondary Outcomes

Measure	Description	Time Frame
Mean IOP		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of primary open-angle glaucoma
Male or female at least 18 years of age and able to provide written informed consent
Mean IOP (at baseline visit after washout of any medications) must be at least 22 mm Hg and no greater than 38 mm Hg
Likely to be available and willing to attend follow-up visits

Exclusion Criteria:

Angle closure glaucoma
Secondary glaucomas
Prior glaucoma procedures
Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeff Wells, PharmD, MBA	Glaukos Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
S.V. Malayan's Ophtalmology Centre		Yerevan		375108	Armenia
Allgemeines Krankenhaus Wien

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24452726	Result	Voskanyan L, Garcia-Feijoo J, Belda JI, Fea A, Junemann A, Baudouin C; Synergy Study Group. Prospective, unmasked evaluation of the iStent(R) inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014 Feb;31(2):189-201. doi: 10.1007/s12325-014-0095-y. Epub 2014 Jan 23.

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

ID	Term
D005901	Glaucoma
D005128	Eye Diseases
D005902	Glaucoma, Open-Angle