Post-Injection Intraocular Pressure SpikesNCT03513172
Pre-Administration of Brimonidine in Intravitreal Anti-VEGF Therapy
A study testing topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) in people with Post-Injection Intraocular Pressure Spikes, run by University of Toronto.
Trial summary
In this study, investigators will be examining the intraocular pressure lowering effect of brimonidine 0.15% when administered 20min prior to intravitreal anti-VEGF injection. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Post-Injection Intraocular Pressure Spikes
- What is being tested?
- topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2016to 1 Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- received ≥1 treatments for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO)
Who cannot join
- baseline diagnosis of glaucoma
- baseline IOP during last visit of greater than 21 mmHg
- ongoing use of topical medications (eg. corticosteroids)
- pseudophakic with an anterior chamber intraocular lens
- history of ocular conditions that may impact IOP (eg. pseudoexfoliation)
- previous in-office (eg. laser peripheral iridotomy) and vitreoretinal surgical procedures (eg. pars plana vitrectomy).
About this study
Official title: Hypotensive Efficacy of Topical Prophylaxis for Intraocular Pressure Spikes Following Intravitreal Injections of Anti-vascular Endothelial Growth Factor Agents
In this study, investigators will be examining the intraocular pressure lowering effect of brimonidine 0.15% when administered 20min prior to intravitreal anti-VEGF injection.
Read the detailed description
A total of 55 consecutive patients undergoing anti-VEGF intravitreal injections (received ≥1 treatments) for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO) will be prospectively recruited between December 2016 and July 2017. Patients will be randomly assigned based on a pre-determined allocation sequence to receive topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) during either the first or second of two consecutive visits. A standard protocol for sterile preparation with topical 5% povidone-iodine solution will be followed. Pre-injection IOP measurements will be recorded prior to the instillation of dilating agents and brimonidine tartrate. A total of three IOP measurements will be taken by certified ophthalmic technicians at immediately after the injection (T0), 10 minutes after (T10) and 20 minutes after (T20) injection.
- Being tested
- topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)
- Keywords
- Intraocular Pressure, Anti-VEGF Agents, alpha2-agonists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)Drug
The rapid hypotensive effects of topical alpha2-agonists such as brimonidine tartrate on decreasing aqueous production and increasing uveoscleral outflow, in addition to their neuroprotective properties, make them an attractive option for prophylactic treatment of post-injection IOP spikes.
| Study group | Role | What they receive |
|---|---|---|
| Brimonidine Pre-Administration During First Visit | Active comparator | Not described Receives: Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) |
| Brimonidine Pre-Administration During Second Visit | Active comparator | Not described Receives: Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-Injection Intraocular Pressure Spike
the intraocular pressure lowering effect of brimonidine 0.15% ophthalmic eye drop when administered 20 minutes prior to intravitreal anti-VEGF injection
Measured: Change from immediately, 10 minutes and 20 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 posted1 May 2018
- Study start15 Dec 2016
- Primary completion15 Jul 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Injection Intraocular Pressure SpikesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Efrem Mandelcorn
- Responsible party
- Principal investigator, Tina Felfeli, University of Toronto
- Investigators
- Efrem Mandelcorn, MD, FRCSC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513172
- Sponsor's protocol ID
- 15-9762-B
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kampougeris G, Spyropoulos D, Mitropoulou A. Intraocular Pressure rise after Anti-VEGF Treatment: Prevalence, Possible Mechanisms and Correlations. J Curr Glaucoma Pract. 2013 Jan-Apr;7(1):19-24. doi: 10.5005/jp-journals-10008-1132. Epub 2013 Jan 15.
PubMed 26997776Kim YJ, Sung KR, Lee KS, Joe SG, Lee JY, Kim JG, Yoon YH. Long-term effects of multiple intravitreal antivascular endothelial growth factor injections on intraocular pressure. Am J Ophthalmol. 2014 Jun;157(6):1266-1271.e1. doi: 10.1016/j.ajo.2014.02.035. Epub 2014 Feb 18.
PubMed 24561173Hoang QV, Mendonca LS, Della Torre KE, Jung JJ, Tsuang AJ, Freund KB. Effect on intraocular pressure in patients receiving unilateral intravitreal anti-vascular endothelial growth factor injections. Ophthalmology. 2012 Feb;119(2):321-6. doi: 10.1016/j.ophtha.2011.08.011. Epub 2011 Nov 4.
PubMed 22054994Tseng JJ, Vance SK, Della Torre KE, Mendonca LS, Cooney MJ, Klancnik JM, Sorenson JA, Freund KB. Sustained increased intraocular pressure related to intravitreal antivascular endothelial growth factor therapy for neovascular age-related macular degeneration. J Glaucoma. 2012 Apr-May;21(4):241-7. doi: 10.1097/IJG.0b013e31820d7d19.
PubMed 21423038Aref AA. Management of immediate and sustained intraocular pressure rise associated with intravitreal antivascular endothelial growth factor injection therapy. Curr Opin Ophthalmol. 2012 Mar;23(2):105-10. doi: 10.1097/ICU.0b013e32834ff41d.
PubMed 22249237Felfeli T, Hostovsky A, Trussart R, Yan P, Brent MH, Mandelcorn ED. Hypotensive efficacy of topical brimonidine for intraocular pressure spikes following intravitreal injections of antivascular endothelial growth factor agents: a randomised crossover trial. Br J Ophthalmol. 2019 Oct;103(10):1388-1394. doi: 10.1136/bjophthalmol-2018-312603. Epub 2018 Dec 20.
PubMed 30573499
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotensive Efficacy of Topical Prophylaxis for Intraocular Pressure Spikes Following Intravitreal Injections of Anti-vascular Endothelial Growth Factor Agents
- ClinicalTrials.gov ID
- NCT03513172
- Acronym / sponsor ID
- 15-9762-B
- Keywords
- Intraocular Pressure, Anti-VEGF Agents, alpha2-agonists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Dr. Efrem Mandelcorn
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 1 May 2018 (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.
In this study, investigators will be examining the intraocular pressure lowering effect of brimonidine 0.15% when administered 20min prior to intravitreal anti-VEGF injection.
Detailed description
A total of 55 consecutive patients undergoing anti-VEGF intravitreal injections (received ≥1 treatments) for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO) will be prospectively recruited between December 2016 and July 2017. Patients will be randomly assigned based on a pre-determined allocation sequence to receive topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) during either the first or second of two consecutive visits. A standard protocol for sterile preparation with topical 5% povidone-iodine solution will be followed. Pre-injection IOP measurements will be recorded prior to the instillation of dilating agents and brimonidine tartrate. A total of three IOP measurements will be taken by certified ophthalmic technicians at immediately after the injection (T0), 10 minutes after (T10) and 20 minutes after (T20) injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brimonidine Pre-Administration During First Visit | Active comparator | Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) |
| Brimonidine Pre-Administration During Second Visit | Active comparator | Drug: topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- received ≥1 treatments for age-related macular degeneration (AMD), diabetic macular edema (DME) or macula edema secondary to branch retinal vein occlusion (BRVO)
Key exclusion criteria (6 listed)
- baseline diagnosis of glaucoma
- baseline IOP during last visit of greater than 21 mmHg
- ongoing use of topical medications (eg. corticosteroids)
- pseudophakic with an anterior chamber intraocular lens
- history of ocular conditions that may impact IOP (eg. pseudoexfoliation)
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 |
|---|---|---|
| topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)The rapid hypotensive effects of topical alpha2-agonists such as brimonidine tartrate on decreasing aqueous production and increasing uveoscleral outflow, in addition to their neuroprotective properties, make them an attractive option for prophylactic treatment of post-injection IOP spikes. | Drug | Brimonidine Pre-Administration During First Visit, Brimonidine Pre-Administration During Second Visit |
Primary outcome
Change in Post-Injection Intraocular Pressure Spike
Time frame: Change from immediately, 10 minutes and 20 minutes after injection
the intraocular pressure lowering effect of brimonidine 0.15% ophthalmic eye drop when administered 20 minutes prior to intravitreal anti-VEGF 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 1 May 2018.
- Background: PubMed 26997776Kampougeris G, Spyropoulos D, Mitropoulou A. Intraocular Pressure rise after Anti-VEGF Treatment: Prevalence, Possible Mechanisms and Correlations. J Curr Glaucoma Pract. 2013 Jan-Apr;7(1):19-24. doi: 10.5005/jp-journals-10008-1132. Epub 2013 Jan 15.
- Background: PubMed 24561173Kim YJ, Sung KR, Lee KS, Joe SG, Lee JY, Kim JG, Yoon YH. Long-term effects of multiple intravitreal antivascular endothelial growth factor injections on intraocular pressure. Am J Ophthalmol. 2014 Jun;157(6):1266-1271.e1. doi: 10.1016/j.ajo.2014.02.035. Epub 2014 Feb 18.
- Background: PubMed 22054994Hoang QV, Mendonca LS, Della Torre KE, Jung JJ, Tsuang AJ, Freund KB. Effect on intraocular pressure in patients receiving unilateral intravitreal anti-vascular endothelial growth factor injections. Ophthalmology. 2012 Feb;119(2):321-6. doi: 10.1016/j.ophtha.2011.08.011. Epub 2011 Nov 4.
- Background: PubMed 21423038Tseng JJ, Vance SK, Della Torre KE, Mendonca LS, Cooney MJ, Klancnik JM, Sorenson JA, Freund KB. Sustained increased intraocular pressure related to intravitreal antivascular endothelial growth factor therapy for neovascular age-related macular degeneration. J Glaucoma. 2012 Apr-May;21(4):241-7. doi: 10.1097/IJG.0b013e31820d7d19.
- Background: PubMed 22249237Aref AA. Management of immediate and sustained intraocular pressure rise associated with intravitreal antivascular endothelial growth factor injection therapy. Curr Opin Ophthalmol. 2012 Mar;23(2):105-10. doi: 10.1097/ICU.0b013e32834ff41d.
- Derived from this study: PubMed 30573499Felfeli T, Hostovsky A, Trussart R, Yan P, Brent MH, Mandelcorn ED. Hypotensive efficacy of topical brimonidine for intraocular pressure spikes following intravitreal injections of antivascular endothelial growth factor agents: a randomised crossover trial. Br J Ophthalmol. 2019 Oct;103(10):1388-1394. doi: 10.1136/bjophthalmol-2018-312603. Epub 2018 Dec 20.
- Individual participant dataSharing planned: Undecided
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.
Efrem Mandelcorn, MD, FRCSC principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
A study testing topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc) in people with Post-Injection Intraocular Pressure Spikes, run by University of Toronto.
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 6 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 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Post-Injection Intraocular Pressure Spike (time frame: Change from immediately, 10 minutes and 20 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 NCT03513172, which also lists 6 linked publications.
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 1 May 2018.