Intraocular Pressure Change in Intravitreal InjectionNCT02140450
Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection
A study testing Timolol, Brimonidine and Acetazolamide in people with Intraocular Pressure Change in Intravitreal Injection, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure Change in Intravitreal Injection
- What is being tested?
- Timolol, Brimonidine and Acetazolamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Feb 2012to May 2014
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients who candidate for receiving intravitreal bevacizumab
Who cannot join
- patients who had advanced glaucoma
- patients who received antiglaucoma agents in the past
- patients who had corneal scar which affect IOP measurement
Trial locations and contacts
1 site in 1 country.
Iran1 site
Retina Research Center, Khatam eye Hospital
Mashhad, Razavi Khorasan Province
About this study
Official title: Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection: the Effect of Pretreatment With Antiglaucoma Agents
To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection.
Read the detailed description
Acute intraocular pressure elevation after intravitreal injection of bevacizumab was proven.Acute intraocular pressure elevation most probably is volume related and long term intraocular pressure elevation relates to pharmacologic features of the medications which results in anatomic changes in the angle of anterior chamber.Numerous studies found an intraocular pressure elevation right after the injection and quick normalization within maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can result in irreversible visual loss especially in patients with critical remaining nerve fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to prevent or even shorten this time of intraocular pressure elevation? We tried in our study to find a suitable response for a question above, so we used several anti-glaucoma agents (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent acute intraocular pressure elevation right after intravitreal bevacizumab injection.
- Being tested
- Timolol, Brimonidine, Acetazolamide, Mannitol, Placebo
- Keywords
- intraocular pressure, intravitreal injection, short term
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimololDrug
Also called Timoptic
2 drops of timolol, 10 minutes apart, 1-2 hours before intravitreal injection
BrimonidineDrug
Also called Alphagan
Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
AcetazolamideDrug
Also called Diamox
Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection
MannitolDrug
Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection
PlaceboDrug
Also called Sham
Artificial tears, 2 drops, 1-2 hours before intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Timolol | Active comparator | Timolol eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection Receives: Drug: Timolol |
| Brimonidine | Active comparator | Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection Receives: Drug: Brimonidine |
| Acetazolamide | Active comparator | Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection Receives: Drug: Acetazolamide |
| Mannitol | Active comparator | Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection Receives: Drug: Mannitol |
| Placebo | Sham comparator | Artificial tears, 2 drops, 1-2 hours before intravitreal injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in IOP
the change in intraocular pressure after intravitreal injection of bevacizumab
Measured: 0, 5, 10, 15, 30 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startFeb 2012
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraocular Pressure Change in Intravitreal InjectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Shoeibi, Mashhad University of Medical Sciences
- Investigators
- Nasser Shoeibi, M.D., Principal investigator, Retina Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140450
- Sponsor's protocol ID
- 910292
- Status last verified
- May 2014
- First submitted
- 9 May 2014
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shoeibi N, Ghosi Z, Jafari H, Omidtabrizi A. Effect of antiglaucoma agents on short-term intraocular pressure fluctuations after intravitreal bevacizumab injections. Int Ophthalmol. 2021 Mar;41(3):1081-1090. doi: 10.1007/s10792-020-01667-z. Epub 2021 Jan 2.
PubMed 33389369
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection: the Effect of Pretreatment With Antiglaucoma Agents
- ClinicalTrials.gov ID
- NCT02140450
- Acronym / sponsor ID
- 910292
- Keywords
- intraocular pressure, intravitreal injection, short term
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 May 2014 (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.
To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection.
Detailed description
Acute intraocular pressure elevation after intravitreal injection of bevacizumab was proven.Acute intraocular pressure elevation most probably is volume related and long term intraocular pressure elevation relates to pharmacologic features of the medications which results in anatomic changes in the angle of anterior chamber.Numerous studies found an intraocular pressure elevation right after the injection and quick normalization within maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can result in irreversible visual loss especially in patients with critical remaining nerve fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to prevent or even shorten this time of intraocular pressure elevation? We tried in our study to find a suitable response for a question above, so we used several anti-glaucoma agents (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent acute intraocular pressure elevation right after intravitreal bevacizumab injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Timolol | Active comparator | Drug: TimololTimolol eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection |
| Brimonidine | Active comparator | Drug: BrimonidineBrimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection |
| Acetazolamide | Active comparator | Drug: AcetazolamideAcetazolamide tablet, 2 tabs, 2 hours before intravitreal injection |
| Mannitol | Active comparator | Drug: MannitolIntravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection |
| Placebo | Sham comparator | Drug: PlaceboArtificial tears, 2 drops, 1-2 hours before intravitreal injection |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who candidate for receiving intravitreal bevacizumab
Key exclusion criteria (3 listed)
- patients who had advanced glaucoma
- patients who received antiglaucoma agents in the past
- patients who had corneal scar which affect IOP measurement
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 |
|---|---|---|
| TimololAlso: Timoptic2 drops of timolol, 10 minutes apart, 1-2 hours before intravitreal injection | Drug | Timolol |
| BrimonidineAlso: AlphaganBrimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection | Drug | Brimonidine |
| AcetazolamideAlso: DiamoxAcetazolamide tablet, 2 tabs, 2 hours before intravitreal injection | Drug | Acetazolamide |
| MannitolIntravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection | Drug | Mannitol |
| PlaceboAlso: ShamArtificial tears, 2 drops, 1-2 hours before intravitreal injection | Drug | Placebo |
Primary outcome
change in IOP
Time frame: 0, 5, 10, 15, 30 minutes after injection
the change in intraocular pressure after intravitreal injection of bevacizumab
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 16 May 2014.
- Derived from this study: PubMed 33389369Shoeibi N, Ghosi Z, Jafari H, Omidtabrizi A. Effect of antiglaucoma agents on short-term intraocular pressure fluctuations after intravitreal bevacizumab injections. Int Ophthalmol. 2021 Mar;41(3):1081-1090. doi: 10.1007/s10792-020-01667-z. Epub 2021 Jan 2.
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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.
Nasser Shoeibi, M.D. principal investigator
Retina Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timolol, Brimonidine and Acetazolamide in people with Intraocular Pressure Change in Intravitreal Injection, run by Mashhad University of Medical Sciences 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 3 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 16 May 2014. 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.
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?
change in IOP (time frame: 0, 5, 10, 15, 30 minutes after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140450, which also lists 1 linked publication.
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 16 May 2014.