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

Glaucoma Clinical Trial

— SY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911924
• Other study ID #: Synergy
• Secondary ID: Synergy Trial
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2009
• Last updated: May 18, 2015
• Start date: May 2009
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeGreece: Ethics CommitteeAustria: EthikkommissionGermany: Ethics CommissionSpain: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Diseases
• Glaucoma
• Glaucoma, Open-Angle

Intervention

Device:
• iStent
Glaukos iStent, medication

Locations

Country	Name	City	State
Armenia	S.V. Malayan's Ophtalmology Centre	Yerevan
Austria	Allgemeines Krankenhaus Wien	Wien
France	Chu de Lyon Hospital Edouard Herriot	Lyon
France	CHNO des Quinze-Vingts	Paris
France	Hopital Saint-Joseph	Paris
Germany	Knapschaftskrankenhaus Bochum Langendreer	Bochum
Germany	Universitatsklinkum Erlangen	Erlangen
Germany	Universitatsklinikum Magdeburg A.o.R.	Magdeburg
Germany	Dietrich-Bonhoeffer-Klinikum Neubrandenburg	Neubrandenburg
Italy	Universita' degli Studi di Parma	Parma
Italy	Universita'di Torino	Torino
Spain	Hospital clinico San Carlos	Madrid
Spain	Hospital Torrevieja Salud, UTE	Torrevieja

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Countries where clinical trial is conducted

Armenia,  Austria,  France,  Germany,  Italy,  Spain, 

References & Publications (1)

Voskanyan L, García-Feijoó J, Belda JI, Fea A, Jünemann A, Baudouin C; Synergy Study Group. Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial. Adv Ther. 2014 Feb;31(2):189-201. doi: 10.1007/s12325-014-009 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOP 18 mm Hg or less without medications		At 6 months	No
Primary	IOP 18 mm Hg or less with or without medications		12 months	No
Secondary	Mean IOP		12 months	No