SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma

NCT ID: NCT00382395

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2017-07-31

Brief Summary

Study Objective:

To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.

Detailed Description

This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.

Conditions

Glaucoma; Glaucoma, Open Angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

SOLX Gold Shunt

Group Type: EXPERIMENTAL

SOLX Gold Shunt GMS-plus

Intervention Type: DEVICE

Single use implant

2

Control Ahmed FP7 Shunt

Group Type: ACTIVE_COMPARATOR

Ahmed FP7 Glaucoma Valve

Intervention Type: DEVICE

Single use implant

Interventions

SOLX Gold Shunt GMS-plus

Single use implant

Intervention Type: DEVICE

Ahmed FP7 Glaucoma Valve

Single use implant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
• Age 21 or over
• refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional glaucoma surgery
• detectable visual field defect (negative MD score)
• written consent
• available for up to 24 months follow-up

Exclusion Criteria

• either eye with VA worse than count fingers
• recent angle closure glaucoma episode
• uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
• other significant ocular disease, except cataract
• active ocular infection
• expected ocular surgery in next 12 months
• no suitable quadrant for implant
• systemic corticosteroid therapy > 5 mg/day prednisone
• intolerance to gonioscopy or other eye exams
• mental impairment interfering with consent or compliance
• pregnancy
• known sensitivity to anticipated medications used at surgery
• significant co-morbid disease
• concurrent enrollment in another drug or device study

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SOLX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

SOLX, Inc.

Principal Investigators

Jan S. Peterson, MS, RAC

Role: STUDY_DIRECTOR

The Emmes Company, LLC

Locations

North Bay Eye Associates

Petaluma, California, United States

Glaucoma Consultants of Colorado

Littleton, Colorado, United States

International Eye Care

Tampa, Florida, United States

Price Vision Group

Indianapolis, Indiana, United States

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, United States

Glaucoma Associates of New York

New York, New York, United States

Eagle Mountain Vision

Tulsa, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Tennessee / Hamilton Eye Institute

Memphis, Tennessee, United States

Credit Valley EyeCare

Mississauga, Ontario, Canada

Institut du Glaucome de Montréal

Montreal, Quebec, Canada

Bombay City Eye Institute & Research Centre

Mumbai, Maharashtra, India

Vision Research Foundation / Sankara Nethralaya

Chennai, Tamil Nadu, India

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Military Institute of the Health Services

Warsaw, , Poland

Countries

United States; Canada; India; Israel; Poland

Other Identifiers

SLX53

Identifier Type: -

Identifier Source: org_study_id