GlaucomaBPACNCT01159314
Baerveldt Plate Area Comparison (BPAC)
A study testing Baerveldt Device surgical Procedure in people with Glaucoma, run by Johns Hopkins University at 5 sites in United States.
Trial summary
This research is being done to compare the safety and effectiveness of two sizes of the Baerveldt glaucoma implant. A Baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Baerveldt Device surgical Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2010to 4 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Intra-Ocular Pressure (IOP) > 18 mm Hg and < 40 mm Hg on medical therapy
- Previous ocular surgery limited to (cataract, corneal transplant, trabeculectomy, vitrectomy)
- Consent signed
Who cannot join
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
- Pregnant or nursing
- Neuro-Linguistic Programming (NLP) vision
- Iris neovascularization or proliferative retinopathy
- Epithelial or fibrous downgrowth
- Chronic or recurrent uveitis
Show all 15Show fewer
- Steroid-induced glaucoma
- Severe posterior blepharitis
- Previous cyclodestructive procedure
- Conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. Stevens Johnson syndrome, ocular pemphigoid) precluding Baerveldt implantation.
- Functionally significant cataract
- Need for Baerveldt implant combined with other ocular procedures (ie cataract surgery,penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery
- Prior glaucoma drainage device (tube) implant
- Prior retinal surgery with remaining silicone oil
- Prior scleral buckling procedures
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Wilmer Eye Institute
Baltimore, Maryland, 21287
U. Miami/Bascom Palmer
Miami, Florida, 33136
Mount Sinai School of Medicine
New York, New York, 10029
Wills Eye Institute
Philadelphia, Pennsylvania
University of California - Davis
Sacramento, California, 95817-2307
About this study
This research is being done to compare the safety and effectiveness of two sizes of the Baerveldt glaucoma implant.
A Baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. This procedure works by providing a route by which fluid can drain out of the eye to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white portion of the eye). It is this plate that comes in two different sizes (250 square millimeters and 350 square millimeters).
Earlier studies have shown that larger plate sizes produce lower eye pressures but that they may also result in more complications. While both Baerveldt devices are currently in use and have been shown to be safe and effective, it is unclear if one is superior to the other. The purpose of this study is to see if one size of device works better with fewer complications.
- Conditions
- Glaucoma
- Being tested
- Baerveldt Device surgical Procedure
- Keywords
- glaucoma, Baerveldt Implants
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baerveldt Device surgical ProcedureProcedure or surgery
Implant surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Baerveldt 250 mm2 | Experimental | Patients receiving Baerveldt 250 mm2 Receives: Procedure: Baerveldt Device surgical Procedure |
| Arm B - Baerveldt 350 mm2 | Experimental | Patients receiving Baerveldt 350 mm2 Receives: Procedure: Baerveldt Device surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS)
Visual acuity is an important outcome variable in the BPAC. Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing will be employed at the Qualifying Assessment and at every follow-up visit.The patient starts are the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. ETDRS visual acuity is required at the Qualifying Assessment and at the 1 year, 3 year, and 5 year follow-up visits
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJun 2010
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Boland, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159314
- Sponsor's protocol ID
- NA_00037146
- Acronym
- BPAC
- Status last verified
- Apr 2018
- First submitted
- 8 Jul 2010
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baerveldt Plate Area Comparison (BPAC)
- ClinicalTrials.gov ID
- NCT01159314
- Acronym / sponsor ID
- BPAC / NA_00037146
- Conditions
- Glaucoma
- Keywords
- glaucoma, Baerveldt Implants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to compare the safety and effectiveness of two sizes of the Baerveldt glaucoma implant.
A Baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. This procedure works by providing a route by which fluid can drain out of the eye to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white portion of the eye). It is this plate that comes in two different sizes (250 square millimeters and 350 square millimeters).
Earlier studies have shown that larger plate sizes produce lower eye pressures but that they may also result in more complications. While both Baerveldt devices are currently in use and have been shown to be safe and effective, it is unclear if one is superior to the other. The purpose of this study is to see if one size of device works better with fewer complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Baerveldt 250 mm2 | Experimental | Procedure: Baerveldt Device surgical ProcedurePatients receiving Baerveldt 250 mm2 |
| Arm B - Baerveldt 350 mm2 | Experimental | Procedure: Baerveldt Device surgical ProcedurePatients receiving Baerveldt 350 mm2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18
- Intra-Ocular Pressure (IOP) > 18 mm Hg and < 40 mm Hg on medical therapy
- Previous ocular surgery limited to (cataract, corneal transplant, trabeculectomy, vitrectomy)
- Consent signed
Key exclusion criteria (15 listed)
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
- Pregnant or nursing
- Neuro-Linguistic Programming (NLP) vision
- Iris neovascularization or proliferative retinopathy
- Epithelial or fibrous downgrowth
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 |
|---|---|---|
| Baerveldt Device surgical ProcedureImplant surgery | Procedure or surgery | Arm A - Baerveldt 250 mm2, Arm B - Baerveldt 350 mm2 |
Primary outcome
Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS)
Time frame: Up to 5 years
Visual acuity is an important outcome variable in the BPAC. Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing will be employed at the Qualifying Assessment and at every follow-up visit.The patient starts are the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. ETDRS visual acuity is required at the Qualifying Assessment and at the 1 year, 3 year, and 5 year follow-up visits
Results and safety
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
Related trials for Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
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.
Michael Boland, MD, PhD principal investigator
Johns Hopkins University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baerveldt Device surgical Procedure in people with Glaucoma, run by Johns Hopkins University at 5 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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
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?
Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2018.