Eye DiseasesNCT04523844
Brinzolamide-brimonidine Fixed Combination for Preventing IOP Elevation After Intravitreal Anti-VEGF Injections
A study testing Brinzolamide-brimonidine Fixed Combination in people with Eye Diseases and Injection Complication, run by General Hospital of Athens Elpis at 1 site in Greece.
Trial summary
This study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Eye Diseases, Injection Complication, Intraocular Pressure
- What is being tested?
- Brinzolamide-brimonidine Fixed Combination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGreece
- Study dates
- 11 May 2020to 30 Jul 2020
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors
Who cannot join
- history of glaucoma or ocular hypertension
- use of topical medications (e.g. IOP-lowering medication, corticosteroids)
- pseudoexfoliation
- pigment dispersion syndrome
- corneal diseases
- active intraocular inflammation
- any intraocular surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Prophylaxis With Brinzolamide-brimonidine Fixed Combination on Intraocular Pressure Elevation After Intravitreal Injections of Anti-vascular Endothelial Growth Factors
This study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF).
Patients scheduled for treatment with intravitreal injections of anti-VEGF will be randomly divided into two groups. In control group no prophylactic medication will be used, whereas in case group one drop of brinzolamide-brimonidine fixed combination will be instilled two hours before the injection. IOP will be measured before the injection, 1 minute after the injection, 10 minutes and 30 minutes post-injection in all eyes. In case group, the pre-injection IOP will be measured prior to the administration of the fixed combination of brinzolamide-brimonidine. The iCare (IC200) tonometer will be used for IOP measurements at all time points.
Read the detailed description
The intravitreal anti-VEGF (ranibizumab, bevacizumab, pegaptanib and aflibercept) are commonly used in the treatment of diabetic macular edema, neovascular age-related macular degeneration and other pathologies characterized by retinal or choroidal neovascularization. Intravitreal injections οf anti-VEGF agents result in an immediate and transient increase in IOP, which returns to normal within a short period of time, typically within thirty minutes. Repeated intravitreal injections and prolonged treatments seem to be associated with sustained elevation of IOP, leading to the initiation of ocular hypotensive medication and glaucoma filtration surgery. A fixed-dose combination of brinzolamide 1%, a carbonic anhydrase inhibitor, and brimonidine 0,2%, an alpha 2 adrenergic receptor agonist, represents a safe and effective drug in glaucoma treatment and its ocular hypotensive effect has been demonstrated similar to or better than the unfixed combinations of its component drugs.
- Conditions
- Eye Diseases, Injection Complication, Intraocular Pressure
- Being tested
- Brinzolamide-brimonidine Fixed Combination
- Keywords
- anti-vascular endothelial growth factor, intraocular pressure, brinzolamide, brimonidine, fixed combination
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brinzolamide-brimonidine Fixed CombinationDrug
Also called Simbrinza 0.2%-1% Ophthalmic Suspension
In case group one drop of a fixed combination of brinzolamide-brimonidine will be instilled two hours before the injection
| Study group | Role | What they receive |
|---|---|---|
| Brinzolamide-brimonidine fixed combination | Active comparator | One drop of the brinzolamide-brimonidine fixed combination is instilled in the eyes of patients two hours before the intravitreal injection Receives: Drug: Brinzolamide-brimonidine Fixed Combination |
| No topical IOP-lowering medication | No intervention | No IOP-lowering drops are instilled before the intravitreal injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP at 1 minute post-injection
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
Measured: 1 minute post-injection
Secondary outcomes (2)
IOP at 10 minutes post-injection
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
Measured: 10 minutes post-injection
IOP at 30 minutes post-injection
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
Measured: 30 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start11 May 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Athens Elpis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Dettoraki, General Hospital of Athens Elpis
- Investigators
- Maria Dettoraki, MD, PhD, Principal investigator, "Elpis" General Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523844
- Sponsor's protocol ID
- 1992
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Prophylaxis With Brinzolamide-brimonidine Fixed Combination on Intraocular Pressure Elevation After Intravitreal Injections of Anti-vascular Endothelial Growth Factors
- ClinicalTrials.gov ID
- NCT04523844
- Acronym / sponsor ID
- 1992
- Conditions
- Eye Diseases, Injection Complication, Intraocular Pressure
- Keywords
- anti-vascular endothelial growth factor, intraocular pressure, brinzolamide, brimonidine, fixed combination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- General Hospital of Athens ElpisUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 24 Aug 2020 (actual)
- 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 study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF).
Patients scheduled for treatment with intravitreal injections of anti-VEGF will be randomly divided into two groups. In control group no prophylactic medication will be used, whereas in case group one drop of brinzolamide-brimonidine fixed combination will be instilled two hours before the injection. IOP will be measured before the injection, 1 minute after the injection, 10 minutes and 30 minutes post-injection in all eyes. In case group, the pre-injection IOP will be measured prior to the administration of the fixed combination of brinzolamide-brimonidine. The iCare (IC200) tonometer will be used for IOP measurements at all time points.
Detailed description
The intravitreal anti-VEGF (ranibizumab, bevacizumab, pegaptanib and aflibercept) are commonly used in the treatment of diabetic macular edema, neovascular age-related macular degeneration and other pathologies characterized by retinal or choroidal neovascularization. Intravitreal injections οf anti-VEGF agents result in an immediate and transient increase in IOP, which returns to normal within a short period of time, typically within thirty minutes. Repeated intravitreal injections and prolonged treatments seem to be associated with sustained elevation of IOP, leading to the initiation of ocular hypotensive medication and glaucoma filtration surgery. A fixed-dose combination of brinzolamide 1%, a carbonic anhydrase inhibitor, and brimonidine 0,2%, an alpha 2 adrenergic receptor agonist, represents a safe and effective drug in glaucoma treatment and its ocular hypotensive effect has been demonstrated similar to or better than the unfixed combinations of its component drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brinzolamide-brimonidine fixed combination | Active comparator | Drug: Brinzolamide-brimonidine Fixed CombinationOne drop of the brinzolamide-brimonidine fixed combination is instilled in the eyes of patients two hours before the intravitreal injection |
| No topical IOP-lowering medication | No intervention | –No IOP-lowering drops are instilled before the intravitreal injections |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors
Key exclusion criteria (7 listed)
- history of glaucoma or ocular hypertension
- use of topical medications (e.g. IOP-lowering medication, corticosteroids)
- pseudoexfoliation
- pigment dispersion syndrome
- corneal diseases
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 |
|---|---|---|
| Brinzolamide-brimonidine Fixed CombinationAlso: Simbrinza 0.2%-1% Ophthalmic SuspensionIn case group one drop of a fixed combination of brinzolamide-brimonidine will be instilled two hours before the injection | Drug | Brinzolamide-brimonidine fixed combination |
Primary outcome
IOP at 1 minute post-injection
Time frame: 1 minute post-injection
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
2 secondary outcomes
IOP at 10 minutes post-injection
Time frame: 10 minutes post-injection
IOP at 30 minutes post-injection
Time frame: 30 minutes post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
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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.
Maria Dettoraki, MD, PhD principal investigator
"Elpis" General Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brinzolamide-brimonidine Fixed Combination in people with Eye Diseases and Injection Complication, run by General Hospital of Athens Elpis at 1 site in Greece.
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 7 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 24 Aug 2020. 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 Greece. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IOP at 1 minute post-injection (time frame: 1 minute post-injection). 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 24 Aug 2020.