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

Primary Purpose

Glaucoma, Glaucoma, Open Angle

Status
Suspended
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SOLX Gold Shunt GMS-plus
Ahmed FP7 Glaucoma Valve
Sponsored by
SOLX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma shunt, Ocular implant, Gold, trabeculectomy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Bay Eye Associates
  • Glaucoma Consultants of Colorado
  • International Eye Care
  • Price Vision Group
  • University of Medicine and Dentistry of New Jersey
  • Glaucoma Associates of New York
  • Eagle Mountain Vision
  • University of Pittsburgh Medical Center
  • University of Tennessee / Hamilton Eye Institute
  • Credit Valley EyeCare
  • Institut du Glaucome de Montréal
  • Bombay City Eye Institute & Research Centre
  • Vision Research Foundation / Sankara Nethralaya
  • Chaim Sheba Medical Center
  • Military Institute of the Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

SOLX Gold Shunt

Control Ahmed FP7 Shunt

Outcomes

Primary Outcome Measures

Percentage reduction in IOP at both 12 and 24 months after implant

Secondary Outcome Measures

Absolute IOP
Mean number of glaucoma medications
Success rate

Full Information

First Posted
September 27, 2006
Last Updated
September 17, 2015
Sponsor
SOLX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00382395
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Suspended
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
SOLX, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open Angle
Keywords
Glaucoma shunt, Ocular implant, Gold, trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
SOLX Gold Shunt
Arm Title
2
Arm Type
Active Comparator
Arm Description
Control Ahmed FP7 Shunt
Intervention Type
Device
Intervention Name(s)
SOLX Gold Shunt GMS-plus
Intervention Description
Single use implant
Intervention Type
Device
Intervention Name(s)
Ahmed FP7 Glaucoma Valve
Intervention Description
Single use implant
Primary Outcome Measure Information:
Title
Percentage reduction in IOP at both 12 and 24 months after implant
Time Frame
1 & 2 years
Secondary Outcome Measure Information:
Title
Absolute IOP
Time Frame
1 & 2 years
Title
Mean number of glaucoma medications
Time Frame
1 & 2 years
Title
Success rate
Time Frame
1 & 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan S. Peterson, MS, RAC
Organizational Affiliation
The Emmes Company, LLC
Official's Role
Study Director
Facility Information:
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Glaucoma Consultants of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
International Eye Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Glaucoma Associates of New York
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Eagle Mountain Vision
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74132
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Tennessee / Hamilton Eye Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Credit Valley EyeCare
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5L 1W8
Country
Canada
Facility Name
Institut du Glaucome de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1V 1G5
Country
Canada
Facility Name
Bombay City Eye Institute & Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400 007
Country
India
Facility Name
Vision Research Foundation / Sankara Nethralaya
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 006
Country
India
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Military Institute of the Health Services
City
Warsaw
ZIP/Postal Code
09-909
Country
Poland

12. IPD Sharing Statement

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

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