GlaucomaPhase 3NCT01314170
Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.
A Phase 3 study testing Susanna Implant in people with Glaucoma, run by Adapt Produtos Oftalmológicos Ltda. at 1 site in Brazil.
Trial summary
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna Implant in patients with refractory glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Susanna Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Oct 2011
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neovascular glaucoma group:
- Patient with neovascular glaucoma whose intraocular pressures which must be above 21 in at least three measurements, at different times in at least two different days during one month, despite maximum tolerated medical therapy.
- Visual acuity better than hand movements in the study eye.
- Patients 18 years or more.
- Patients with fixed residence in the health district where the surgery will be performed.
- Patients who fit the term of consent.
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- Group post-trabeculectomy failure:
- Patients diagnosed with primary open angle glaucoma, pseudoesfoliação, pigmented or primary angle closure who underwent surgery with trabeculectomy procedure after failure of at least two months of surgery. The pressure must be above 21 in at least three measurements, at different times in at least two different days during one month, despite maximum tolerated medical therapy.
- Patients diagnosed with primary open angle glaucoma, pseudoesfoliação, pigmented or primary angle closure who underwent surgery with trabeculectomy procedure after failure of at least two months for surgery and who can not afford the expenses of medical treatment. The pressure must be above 21 in at least three measurements, at different times in at least two different days during one month.
- Visual acuity better than hand movements in the study eye.
- Patients 18 years or more.
- Patients with fixed residence in the health district where the surgery will be performed.
- Patients who fit the term of consent.
Who cannot join
- Group post-trabeculectomy failure:
- Presence of staphyloma that does not allow the procedure.
- Presence of history of scleritis
- Presence of psychiatric disorder that has required hospitalization.
- Presence of retinal detachment surgery with placement of a buckle or track.
- Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
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- Presence of shallow anterior chamber that would prevent the placement of the implant.
- Presence of vitreous in aphakia or anterior chamber.
- Presence of psychiatric disorder that has required hospitalization.
- Neovascular glaucoma group:
- Presence of staphyloma that does not allow the procedure.
- Presence of history of scleritis.
- Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
- Presence of shallow anterior chamber that would prevent the placement of the implant.
- Presence of vitreous in aphakia or anterior chamber.
- Presence of retinal detachment surgery with placement of a buckle or track.
- Presence of neovascular glaucoma or other secondary glaucoma.
- Presence of psychiatric disorder that has required hospitalization.
Trial locations and contacts
1 site in 1 country.
Augusto Paranhos, Investigator contact
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05651-901
Augusto Paranhos, Investigator, 55 11 3747-3312
Fernanda Lima, Coordinator, 55 11 2151-0723, fernandalima@einstein.br
About this study
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna Implant in patients with refractory glaucoma.
Read the detailed description
Clinical trial multicenter, phase III,open-label, prospective character to evaluate the efficacy and safety of Susanna Implant in patients with refractory glaucoma of both genders, of any race, aged above 18 years and diagnosed with glaucoma refractory.
- Conditions
- Glaucoma
- Being tested
- Susanna Implant
- Keywords
- Implant, glaucoma, refractory glaucoma.
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Susanna ImplantDevice
Also called ADA-VSUS-01-10
device
| Study group | Role | What they receive |
|---|---|---|
| Susanna Implant | No intervention | Patients with refractory glaucoma neovascular type or that failed in trabeculectomy will undergo surgery to place implants Susana. Receives: Device: Susanna Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma.
Evaluate the effectiveness of implant susanna in patients with refractory glaucoma.
Measured: 180 days
Secondary outcomes (1)
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. "
Evaluate the safety of implant susanna in patients with refractory glaucoma. i
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adapt Produtos Oftalmológicos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Remo Susanna, Investigator, Principal investigator, Hospital das Clínicas de São PauloRenato Lisboa, Investigator, Principal investigator, UNIFESP - Universidade Federal de São PauloCláudia Galvão, Investigator, Principal investigator, Hospital Universitário Prof. Edgar Santos - BAFlávia Villas, Investigator, Principal investigator, - Instituto brasileiro de Oftalmologia e prevenção da cegueira- BAFábio Kanadani, Investigator, Principal investigator, Hospital Universitário São José - Belo HorizonteAugusto Paranhos, Investigator, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314170
- Sponsor's protocol ID
- E01-ADA-VSUS-01-10
- Status last verified
- May 2011
- First submitted
- 4 Aug 2010
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Susanna Implant in Patients With Refractory Glaucoma.
- ClinicalTrials.gov ID
- NCT01314170
- Acronym / sponsor ID
- E01-ADA-VSUS-01-10
- Conditions
- Glaucoma
- Keywords
- Implant, glaucoma, refractory glaucoma.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Adapt Produtos Oftalmológicos Ltda.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 14 Mar 2011 (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.
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna Implant in patients with refractory glaucoma.
Detailed description
Clinical trial multicenter, phase III,open-label, prospective character to evaluate the efficacy and safety of Susanna Implant in patients with refractory glaucoma of both genders, of any race, aged above 18 years and diagnosed with glaucoma refractory.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Susanna Implant | No intervention | Device: Susanna ImplantPatients with refractory glaucoma neovascular type or that failed in trabeculectomy will undergo surgery to place implants Susana. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient with neovascular glaucoma whose intraocular pressures which must be above 21 in at least three measurements, at different times in at least two different days during one month, despite maximum tolerated medical therapy.
- Visual acuity better than hand movements in the study eye.
- Patients 18 years or more.
- Patients with fixed residence in the health district where the surgery will be performed.
- Patients who fit the term of consent.
Key exclusion criteria (18 listed)
- Presence of staphyloma that does not allow the procedure.
- Presence of history of scleritis
- Presence of psychiatric disorder that has required hospitalization.
- Presence of retinal detachment surgery with placement of a buckle or track.
- Presence of corneal opacity that could prevent the adequate view of the anterior chamber.
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 |
|---|---|---|
| Susanna ImplantAlso: ADA-VSUS-01-10device | Device | Susanna Implant |
Primary outcome
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma.
Time frame: 180 days
Evaluate the effectiveness of implant susanna in patients with refractory glaucoma.
1 secondary outcome
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. "
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
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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.
Augusto Paranhos, Investigator contact
Remo Susanna, Investigator principal investigator
Hospital das Clínicas de São Paulo
Renato Lisboa, Investigator principal investigator
UNIFESP - Universidade Federal de São Paulo
Cláudia Galvão, Investigator principal investigator
Hospital Universitário Prof. Edgar Santos - BA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Susanna Implant in people with Glaucoma, run by Adapt Produtos Oftalmológicos Ltda. at 1 site in Brazil.
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 13 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Augusto Paranhos, Investigator (55 11 3747-3312), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study clinical multicenter, phase III, open-label, prospective character to evaluate the efficacy and safety Susanna implant in patients with refractory glaucoma. (time frame: 180 days). 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 10 May 2011.