An interventional study of GDD and Amniotic Membrane Graft in Glaucoma, sponsored by BioTissue Holdings, Inc. Completed at 4 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by BioTissue Holdings, Inc · Not applicable, Interventional, and Treatment
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.
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 82 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →BioTissue Holdings, Inc is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with uncontrolled glaucoma undergoing GDD implantation and carry one of the following two strata of high risk factors:
Exclusion Criteria:
After GDD implantation, amniotic membrane graft (AmnioGuard™, Bio-Tissue inc, Miami, FL) is used to cover the GDD tube.
Procedure: GDD · Procedure: Amniotic Membrane Graft
After GDD implantation, a pericardial graft (Tutoplast®, IOP Inc, Costa Mesa, CA) is used to cover the GDD tube.
Procedure: GDD · Procedure: Pericardial Graft
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.
Also known as: Glaucoma drainage device, Tube shunt, Shunt tube, Ahmed Valve, Baerveldt valve
For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.
Also known as: Amnioguard
For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.
Also known as: Tutoplast
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.
Time frame: 2 years
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.
Time frame: 2 years
| Milestone | GDD & Amniotic Membrane Graft | GDD & Pericardial Graft |
|---|---|---|
| Started | 41 | 41 |
| Completed | 41 | 40 |
| Not completed | 0 | 1 |
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.
| Participants | GDD & Amniotic Membrane Graft | GDD & Pericardial Graft |
|---|---|---|
| Number of Participants With Tube Erosion | 2 | 11 |
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.
| Participants | GDD & Amniotic Membrane Graft | GDD & Pericardial Graft |
|---|---|---|
| Number of Participants With Glaucoma Drainage Device Failure | 2 | 2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GDD & Amniotic Membrane Graft | — | 0/41 (0%) | 2/41 (4.9%) |
| GDD & Pericardial Graft | — | 0/41 (0%) | 3/41 (7.3%) |
| Event | GDD & Amniotic Membrane Graft | GDD & Pericardial Graft |
|---|---|---|
| Corneal EdemaEye disorders | 2/41 | 3/41 |
| Age, Continuous(yrs) | GDD & Amniotic Membrane Graft | GDD & Pericardial Graft | Total |
|---|---|---|---|
| Mean | 65.4 ± 13.6 | 68.9 ± 12.3 | 67 ± 13 |
| Sex: Female, Male(Participants) | GDD & Amniotic Membrane Graft | GDD & Pericardial Graft | Total |
|---|---|---|---|
| Female | 22 | 28 | 50 |
| Male | 19 | 12 | 31 |
| Race (NIH/OMB)(Participants) | GDD & Amniotic Membrane Graft | GDD & Pericardial Graft | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 4 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 10 | 28 |
| White | 23 | 26 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BioTissue Holdings, Inc