Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)

Phase 4

Completed

• Conditions: Eye Diseases; Glaucoma; Glaucoma, Open-Angle
• Interventions: Device: iStent; Drug: latanoprost/timolol

• Registration Number: NCT00913029
• Lead Sponsor: Glaukos Corporation

Brief Summary

Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

Detailed Description

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

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 22 mm Hg and no greater than 38 mm Hg
• Likely to be available and willing to attend follow-up visits

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent	iStent	One hundred patients will be randomized to implantation of two G2 stents in at least one eye.
Medication	latanoprost/timolol	One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication.

Primary Outcome Measures

Name	Time	Method
Mean intraocular pressure (IOP)	1 year

Trial Locations

Locations (16)

SV Malayan Ophthalmological Center; 🇦🇲 Yerevan, Armenia

AHEPA Hospital; 🇬🇷 Thessaloniki, Greece

Hospital Torrevieja Salud, UTE; 🇪🇸 Alicante, Spain

Knapschaftskrankenhaus Bochum Langendreer; 🇩🇪 Bochum, Germany

Allgemeines Krankenhaus Wien; 🇦🇹 Wien, Austria

Helios Cliniic; 🇩🇪 Erfurt, Germany

Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica; 🇮🇹 Torino, Italy

CHU de Lyon Hopital Edouard Herriot; 🇫🇷 Lyon, France

Universitatsklinkum Erlangen; 🇩🇪 Erlangen, Germany

CHNO des Quinze-Vingts; 🇫🇷 Paris, France

Universita'degli Studi di Parma; 🇮🇹 Parma, Italy

Azienda Ospedaliera S. Maria della Misericordia; 🇮🇹 Udine, Italy

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hinchingbrooke Hospital Moorfields; 🇬🇧 Bedford, United Kingdom

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Military Health Service Institute; 🇵🇱 Warsaw, Poland