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

Glaucoma Clinical Trial

Official title:

Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00382395
• Other study ID #: SLX53
• Status: Suspended
• Phase: Phase 3
• First received: September 27, 2006
• Last updated: September 17, 2015
• Start date: November 2005
• Est. completion date: July 2017

Study information

• Verified date: September 2015
• Source: SOLX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 180
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open Angle
• Glaucoma, Open-Angle

Intervention

Device:
• SOLX Gold Shunt GMS-plus
Single use implant
• Ahmed FP7 Glaucoma Valve
Single use implant

Locations

Country	Name	City	State
Canada	Credit Valley EyeCare	Mississauga	Ontario
Canada	Institut du Glaucome de Montréal	Montréal	Quebec
India	Vision Research Foundation / Sankara Nethralaya	Chennai	Tamil Nadu
India	Bombay City Eye Institute & Research Centre	Mumbai	Maharashtra
Israel	Chaim Sheba Medical Center	Tel Hashomer
Poland	Military Institute of the Health Services	Warsaw
United States	Price Vision Group	Indianapolis	Indiana
United States	Glaucoma Consultants of Colorado	Littleton	Colorado
United States	University of Tennessee / Hamilton Eye Institute	Memphis	Tennessee
United States	Glaucoma Associates of New York	New York	New York
United States	University of Medicine and Dentistry of New Jersey	Newark	New Jersey
United States	North Bay Eye Associates	Petaluma	California
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	International Eye Care	Tampa	Florida
United States	Eagle Mountain Vision	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
SOLX, Inc.

Countries where clinical trial is conducted

United States,  Canada,  India,  Israel,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage reduction in IOP at both 12 and 24 months after implant		1 & 2 years	No
Secondary	Absolute IOP		1 & 2 years	No
Secondary	Mean number of glaucoma medications		1 & 2 years	No
Secondary	Success rate		1 & 2 years	No