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

Phase 3

Suspended

• Conditions: Glaucoma; Glaucoma, Open Angle

• Registration Number: NCT00382395
• Lead Sponsor: SOLX, Inc.

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-09-27
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-29
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-17
• Last Update Posted: 2015-09-18
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage reduction in IOP at both 12 and 24 months after implant	1 & 2 years

Secondary Outcome Measures

Name	Time	Method
Success rate	1 & 2 years
Absolute IOP	1 & 2 years
Mean number of glaucoma medications	1 & 2 years

Trial Locations

Locations (15)

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

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