Hypertensive PhasePhase 2NCT01814514
Safety Study of Aqueous Suppression After Ahmed Glaucoma Valve (AGV) Implantation
A Phase 2 study testing Timolol-trusopt in people with Hypertensive Phase, run by Zahra Rabbani Khah at 1 site in Iran.
Trial summary
The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Phase
- What is being tested?
- Timolol-trusopt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteIran
- Study dates
- Jan 2011to Mar 2013
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with uncontrolled glaucoma requiring AGV device implantation.
Who cannot join
- History of AGV implantation
- Allergy to Anti glaucoma medication
- unable to come for follow up
- Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
- Learning difficulty- mental illness or severely ill
Trial locations and contacts
1 site in 1 country.
Mohammad pakravan, Associate Professor contact
Iran1 site, 1 recruiting
- Recruiting
Labbafinejad medical center
Tehran
Mohammad Pakravan, Associate Professor, labbafi@hotmail.com
Mohammad Pakravan, Associate Professor
About this study
Official title: Early Intra Ocular- Pressure Control Using Aqueous Suppressive Agents After Ahmed Glaucoma Valve Implantation
The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by the hypertensive period where the IOP tends to rise steadily above 21mmhg.
The hypertensive response seems to occur more commonly after Ahmed GDD surgery than nonvalved implants, It was reported to occur in 40% to 80% of cases. Although the hypertensive phase can last as long as 6 months it is usually during the first 1 to 4 weeks, when there is intense congestion of the bleb wall, that IOP is highest.
Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators induce an inflammatory reaction, and if excessive, will result in fibrosis and poor functioning of the bleb. High pressure within the bleb also results in the secretion of TGF β by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis and poor bleb function. The investigators supposed that with early use of aqueous suppressant medication after AGV implantation, the concentration of inflammatory mediators decreased in subconjunctival space and may lead to better IOP control after shunt surgery.
- Conditions
- Hypertensive Phase
- Being tested
- Timolol-trusopt, placebo
- Keywords
- hypertensive, phase, success rate, AGV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol-trusoptDrug
Also called cosopt
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Timolol-trusopt | Active comparator | Dosage:One drop/12hours,duration:3 months Receives: Drug: Timolol-trusopt |
| placebo,Artificial tear | Placebo comparator | dosage:one drop/12 hours,duration:3 months Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure-hypertensive phase success rate
during first 3 months
Measured: during first 3 months
Secondary outcomes (1)
intraocular pressure success rate
after 12 months
Measured: after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startJan 2011
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive PhaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zahra Rabbani Khah
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Sponsor-investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814514
- Sponsor's protocol ID
- 90166
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intra Ocular- Pressure Control Using Aqueous Suppressive Agents After Ahmed Glaucoma Valve Implantation
- ClinicalTrials.gov ID
- NCT01814514
- Acronym / sponsor ID
- 90166
- Conditions
- Hypertensive Phase
- Keywords
- hypertensive, phase, success rate, AGV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Zahra Rabbani KhahUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (estimated)
- First posted
- 20 Mar 2013 (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.
The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by the hypertensive period where the IOP tends to rise steadily above 21mmhg.
The hypertensive response seems to occur more commonly after Ahmed GDD surgery than nonvalved implants, It was reported to occur in 40% to 80% of cases. Although the hypertensive phase can last as long as 6 months it is usually during the first 1 to 4 weeks, when there is intense congestion of the bleb wall, that IOP is highest.
Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators induce an inflammatory reaction, and if excessive, will result in fibrosis and poor functioning of the bleb. High pressure within the bleb also results in the secretion of TGF β by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis and poor bleb function. The investigators supposed that with early use of aqueous suppressant medication after AGV implantation, the concentration of inflammatory mediators decreased in subconjunctival space and may lead to better IOP control after shunt surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timolol-trusopt | Active comparator | Drug: Timolol-trusoptDosage:One drop/12hours,duration:3 months |
| placebo,Artificial tear | Placebo comparator | Drug: placebodosage:one drop/12 hours,duration:3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with uncontrolled glaucoma requiring AGV device implantation.
Key exclusion criteria (5 listed)
- History of AGV implantation
- Allergy to Anti glaucoma medication
- unable to come for follow up
- Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
- Learning difficulty- mental illness or severely ill
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 |
|---|---|---|
| Timolol-trusoptAlso: cosopt | Drug | Timolol-trusopt |
| placebo | Drug | placebo,Artificial tear |
Primary outcome
intraocular pressure-hypertensive phase success rate
Time frame: during first 3 months
during first 3 months
1 secondary outcome
intraocular pressure success rate
Time frame: after 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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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.
Mohammad pakravan, Associate Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Timolol-trusopt in people with Hypertensive Phase, run by Zahra Rabbani Khah at 1 site in Iran.
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 1 inclusion and 5 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 20 Mar 2013. 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 Iran. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mohammad pakravan, Associate Professor (labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure-hypertensive phase success rate (time frame: during first 3 months). 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 20 Mar 2013.