Clinical trial NCT00382395: SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Glaucoma
Glaucoma, Open Angle
Keywords: Glaucoma shunt
Ocular implant
Gold
trabeculectomy
Lead sponsor: SOLX, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage reduction in IOP at both 12 and 24 months after implant
timeFrame: 1 & 2 years
Secondary outcomes:
measure: Absolute IOP
timeFrame: 1 & 2 years
measure: Mean number of glaucoma medications
timeFrame: 1 & 2 years
measure: Success rate
timeFrame: 1 & 2 years
Other outcomes:
Locations:
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Littleton
country: United States
facility: Glaucoma Consultants of Colorado
state: Colorado
city: Tampa
country: United States
facility: International Eye Care
state: Florida
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
city: Tulsa
country: United States
facility: Eagle Mountain Vision
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee / Hamilton Eye Institute
state: Tennessee
city: Mississauga
country: Canada
facility: Credit Valley EyeCare
state: Ontario
city: Montréal
country: Canada
facility: Institut du Glaucome de Montréal
state: Quebec
city: Mumbai
country: India
facility: Bombay City Eye Institute & Research Centre
state: Maharashtra
city: Chennai
country: India
facility: Vision Research Foundation / Sankara Nethralaya
state: Tamil Nadu
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
city: Warsaw
country: Poland
facility: Military Institute of the Health Services
Study officials:
affiliation: The Emmes Company, LLC
name: Jan S. Peterson, MS, RAC
role: STUDY_DIRECTOR
References: