GlaucomaSTEPSNCT01551550
Shunt Tube Exposure Prevention Study
A study testing GDD, Amniotic Membrane Graft and Pericardial Graft in people with Glaucoma, run by BioTissue Holdings, Inc at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- GDD, Amniotic Membrane Graft and Pericardial Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2013to 3 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with uncontrolled glaucoma undergoing GDD implantation and carry one of the following two strata of high risk factors:
- Primary open angle glaucoma with previous conjunctival cutting surgery including prior failed trabeculectomy.
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bascom Palmer Eye Institute
Miami, Florida, 33136
New York Eye and Ear Infirmary
New York, New York, 10003
Manhattan Eye, Ear, and Throat Hospital
New York, New York, 10021
Harkness Eye Institute/ Columbia University
New York, New York, 10032
About this study
Official title: Amniotic Membrane Versus Pericardium in Reducing Glaucoma Drainage Tube Exposure: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- GDD, Amniotic Membrane Graft, Pericardial Graft
- Keywords
- Glaucoma Drainage Device, Tube Exposure, Amniotic Membrane
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDDProcedure or surgery
Also called Glaucoma drainage device, Tube shunt, Shunt tube, Ahmed Valve
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.
Amniotic Membrane GraftProcedure or surgery
Also called Amnioguard
For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.
Pericardial GraftProcedure or surgery
Also called Tutoplast
For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.
| Study group | Role | What they receive |
|---|---|---|
| GDD & Amniotic Membrane Graft | Experimental | After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube. Receives: Procedure: GDD; Procedure: Amniotic Membrane Graft |
| GDD & Pericardial Graft | Active comparator | After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube. Receives: Procedure: GDD; Procedure: Pericardial Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Tube Erosion
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.
Measured: 2 years
Secondary outcomes (1)
Number of Participants With Glaucoma Drainage Device Failure
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJun 2013
- Primary completionDec 2016
- Study completion3 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI), Bascom Palmer Eye Institute, The New York Eye & Ear Infirmary, Columbia University
- Responsible party
- Sponsor
- Investigators
- Hosam El Sheha, MD, PhD, Principal investigator, BioTissue Holdings, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551550
- Sponsor's protocol ID
- P010-2, Version 4
- Other IDs
- R44EY019785
- Acronym
- STEPS
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2012
- Last updated
- 18 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Anand A, Sheha H, Teng CC, Liebmann JM, Ritch R, Tello C. Use of amniotic membrane graft in glaucoma shunt surgery. Ophthalmic Surg Lasers Imaging. 2011 May-Jun;42(3):184-9. doi: 10.3928/15428877-20110426-01.
PubMed 21563743
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Membrane Versus Pericardium in Reducing Glaucoma Drainage Tube Exposure: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01551550
- Acronym / sponsor ID
- STEPS / P010-2, Version 4
- Conditions
- Glaucoma
- Keywords
- Glaucoma Drainage Device, Tube Exposure, Amniotic Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI), Bascom Palmer Eye Institute, The New York Eye & Ear Infirmary, Columbia University
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- 3 Aug 2019 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 11 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDD & Amniotic Membrane Graft | Experimental | Procedure: GDD, Procedure: Amniotic Membrane GraftAfter GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube. |
| GDD & Pericardial Graft | Active comparator | Procedure: GDD, Procedure: Pericardial GraftAfter GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with uncontrolled glaucoma undergoing GDD implantation and carry one of the following two strata of high risk factors:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDDAlso: Glaucoma drainage device, Tube shunt, Shunt tube, Ahmed ValveThe 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. | Procedure or surgery | GDD & Amniotic Membrane Graft, GDD & Pericardial Graft |
| Amniotic Membrane GraftAlso: AmnioguardFor subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed. | Procedure or surgery | GDD & Amniotic Membrane Graft |
| Pericardial GraftAlso: TutoplastFor subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed. | Procedure or surgery | GDD & Pericardial Graft |
Primary outcome
Number of Participants With Tube Erosion
Time frame: 2 years
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.
1 secondary outcome
Number of Participants With Glaucoma Drainage Device Failure
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21563743Anand A, Sheha H, Teng CC, Liebmann JM, Ritch R, Tello C. Use of amniotic membrane graft in glaucoma shunt surgery. Ophthalmic Surg Lasers Imaging. 2011 May-Jun;42(3):184-9. doi: 10.3928/15428877-20110426-01.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hosam El Sheha, MD, PhD principal investigator
BioTissue Holdings, Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDD, Amniotic Membrane Graft and Pericardial Graft in people with Glaucoma, run by BioTissue Holdings, Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Tube Erosion (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01551550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.