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

Sponsor
SOLX, Inc. (Industry)
Overall Status
Suspended
CT.gov ID
NCT00382395
Collaborator
(none)
180
Enrollment
15
Locations
2
Arms
140
Duration (Months)
12
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SOLX Gold Shunt GMS-plus
  • Device: Ahmed FP7 Glaucoma Valve
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2005
Anticipated Primary Completion Date :
Jul 1, 2017
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

SOLX Gold Shunt

Device: SOLX Gold Shunt GMS-plus
Single use implant
Active Comparator: 2

Control Ahmed FP7 Shunt

Device: Ahmed FP7 Glaucoma Valve
Single use implant

Outcome Measures

Primary Outcome Measures

  1. Percentage reduction in IOP at both 12 and 24 months after implant [1 & 2 years]

Secondary Outcome Measures

  1. Absolute IOP [1 & 2 years]

  2. Mean number of glaucoma medications [1 & 2 years]

  3. Success rate [1 & 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 North Bay Eye Associates Petaluma California United States 94954
2 Glaucoma Consultants of Colorado Littleton Colorado United States 80120
3 International Eye Care Tampa Florida United States 33603
4 Price Vision Group Indianapolis Indiana United States 46260
5 University of Medicine and Dentistry of New Jersey Newark New Jersey United States 07103
6 Glaucoma Associates of New York New York New York United States 10003
7 Eagle Mountain Vision Tulsa Oklahoma United States 74132
8 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
9 University of Tennessee / Hamilton Eye Institute Memphis Tennessee United States 38163
10 Credit Valley EyeCare Mississauga Ontario Canada L5L 1W8
11 Institut du Glaucome de Montréal Montréal Quebec Canada H1V 1G5
12 Bombay City Eye Institute & Research Centre Mumbai Maharashtra India 400 007
13 Vision Research Foundation / Sankara Nethralaya Chennai Tamil Nadu India 600 006
14 Chaim Sheba Medical Center Tel Hashomer Israel 52621
15 Military Institute of the Health Services Warsaw Poland 09-909

Sponsors and Collaborators

  • SOLX, Inc.

Investigators

  • Study Director: Jan S. Peterson, MS, RAC, The Emmes Company, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00382395
Other Study ID Numbers:
  • SLX53
First Posted:
Sep 29, 2006
Last Update Posted:
Sep 18, 2015
Last Verified:
Sep 1, 2015
Keywords provided by , ,
Glaucoma shunt
Ocular implant
Gold
trabeculectomy
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Sep 18, 2015