Shunt Tube Exposure Prevention Study (STEPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Tissue Tech Inc.
Sponsor:
Collaborators:
Bascom Palmer Eye Institute
The New York Eye & Ear Infirmary
Columbia University
Information provided by (Responsible Party):
Tissue Tech Inc.
ClinicalTrials.gov Identifier:
NCT01551550
First received: March 8, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

This is a multi-site randomized clinical trial to evaluate the long-term efficacy of the thicker amniotic membrane graft (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) in reducing shunt tube exposure in patients undergoing glaucoma drainage device implantation.


Condition Intervention Phase
Glaucoma
Procedure: GDD
Procedure: Amniotic Membrane Graft
Procedure: Pericardial Graft
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Amniotic Membrane Versus Pericardium in Reducing Glaucoma Drainage Tube Exposure: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Tissue Tech Inc.:

Primary Outcome Measures:
  • Tube Exposure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Impending conjunctival erosion can be indicated by loss of conjunctival capillaries over the tube, usually 1 to 3 mm from the corneoscleral junction. Definitive tube exposure is accompanied by conjunctival tissue loss, graft melting.


Secondary Outcome Measures:
  • GDD Failure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    GDD Failure, based on reoperation to control the IOP, and also include the defined by the following criteria: (1) IOP ≥21 mm Hg or not reduced by 30% below baseline on two consecutive follow-up visits after 3 months. (2) IOP ≤5 mm Hg on two consecutive follow-up visits after 3 months. (3) Additional glaucoma surgery. (4) Loss of light perception vision.


Estimated Enrollment: 96
Study Start Date: June 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GDD & Amniotic Membrane Graft
After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.
Procedure: GDD
The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.
Other Names:
  • Glaucoma drainage device
  • Tube shunt
  • Shunt tube
  • Ahmed Valve
  • Baerveldt valve
Procedure: Amniotic Membrane Graft
For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.
Other Name: Amnioguard
Active Comparator: GDD & Pericardial Graft
After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.
Procedure: GDD
The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.
Other Names:
  • Glaucoma drainage device
  • Tube shunt
  • Shunt tube
  • Ahmed Valve
  • Baerveldt valve
Procedure: Pericardial Graft
For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.
Other Name: Tutoplast

Detailed Description:

Glaucoma drainage devices (GDDs) have been used in the treatment of high-risk refractory glaucoma. To avoid tube exposure, which may lead to serious eye infection, the implanted GDD tube must be covered by a patch graft, traditionally made of either donor sclera or pericardium. However, these patch grafts still carry a high rate of progressive thinning and erosion, a complication that the investigators speculate results from the lack of cellular infiltration from the surrounding host conjunctival stroma and poor integration of these patch grafts to the host tissue. The investigators further speculate that a thicker version of cryo-preserved amniotic membrane (AM), manufactured by Bio-Tissue, Inc.,could offer better tensile strength, be suitable for tectonic support, and have biological activities to promote cellular infiltration by the surrounding host conjunctival stroma, thus reducing progressive allogeneic patch graft thinning/erosion.

Through SBIR Phase I grant support (R43 EY19785), the investigators have evaluated the thicker AM as an alternative patch graft for covering the GDD tube during the primary implantation. The investigators further monitored the host cell interaction using anterior segment optical coherence tomography (OCT). The investigators have successfully accomplished the proposed aims of the above studies, which demonstrated the short-term stability/efficacy of AM in covering the tube in primary GDD surgery (Phase I-Aim 1) and confirmed the feasibility of using OCT to distinguish host cell infiltration into the AM after transplantation over the GDD tube (Phase I-Aim 2).

In this SBIR Phase II, the investigators propose to conduct a prospective, controlled study to compare the long-term safety and efficacy of the thicker AM (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) to the pericardium (Tutoplast®, IOP Inc, Costa Mesa, CA) in securing the GDD tube and reducing tube exposure and graft thinning in patients with high risk glaucoma. The investigators will also study the risk factors that may contribute to GDD tube exposure.

Accomplishment of this Phase II study will position AM as an effective alternative to the existing patch grafts to reduce tube exposure and enhance the success of GDD implantation, while providing a better aesthetic appearance and allowing visualization of the tube in patients with high risk glaucoma. The investigators speculate that such a graft might also have other clinical applications outside of covering GDD tubes.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with uncontrolled glaucoma undergoing GDD implantation and carry one of the following two strata of high risk factors:

    1. Primary open angle glaucoma with previous conjunctival cutting surgery including prior failed trabeculectomy.
    2. Secondary glaucoma, e.g., neovascular, uveitic, or post-traumatic glaucoma.
  • Age range: 21- 80 years old.
  • Both genders and all ethnic groups comparable with the local community.
  • Patients able and willing to cooperate with investigational plan.
  • Patients able and willing to complete postoperative follow-up.
  • Patients able to understand and willing to sign a written informed consent.

Exclusion Criteria:

  • Ocular infection within 14 days prior to prior to study entry.
  • No light perception vision
  • Previous cyclodestructive procedure.
  • Children under 21 (see Inclusion of Children).
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551550

Contacts
Contact: Ashley Quintana 305-412-0099 aquintana@tissuetechinc.com

Locations
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Principal Investigator: Richard Lee, MD, PhD         
United States, New York
Harkness Eye Institute/ Columbia University Recruiting
New York, New York, United States, 10032
Principal Investigator: Lama Al-Aswad, MD         
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Principal Investigator: Celso Tello, MD         
Sponsors and Collaborators
Tissue Tech Inc.
Bascom Palmer Eye Institute
The New York Eye & Ear Infirmary
Columbia University
Investigators
Principal Investigator: Hosam El Sheha, MD, PhD Tissue Tech Inc.
  More Information

Publications:
Responsible Party: Tissue Tech Inc.
ClinicalTrials.gov Identifier: NCT01551550     History of Changes
Other Study ID Numbers: P010-2, Version 1, R44EY019785
Study First Received: March 8, 2012
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tissue Tech Inc.:
Glaucoma Drainage Device, Tube Exposure, Amniotic Membrane

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014