Vitreoretinal DiseasePhase 4IVTA:PRE-TREATNCT00744666
IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
A Phase 4 study testing Prednisolone 1% topical eye drops in people with Vitreoretinal Disease and Ocular Hypertension, run by Hotel Dieu Hospital at 4 sites in Canada.
Trial summary
Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreoretinal Disease, Ocular Hypertension
- What is being tested?
- Prednisolone 1% topical eye drops
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesCanada
- Study dates
- Sep 2008to Jul 2010
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment
Who cannot join
- < 18 years old
- Pregnancy
- Breast feeding
- hx of uveitis
- hx of neovascularization of the iris or anterior chamber angle
- hx of ocular herpes simplex keratitis
- hx of glaucoma
- Unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
Canada4 sites, 4 recruiting
- Recruiting
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
Jeffery Gale, MD, FRCSC, 613-544-3400 ext. 3391, jeffgaleuwo@yahoo.com
Christina Leung, MD
- Not yet recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Bernard Hurley, MD, FRCSC, (613) 737-8899 ext. 79422, bhurley@Ottawahospital.on.ca
Bernard Hurley, MD, FRCSC
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Kenneth Eng, MD, FRCSC, 416-480-4688, kt_eng@hotmail.com
Peter Kertes, MD, FRCSC
- Not yet recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Brent Michael, MD, FRCSC, 416-603-5444, mh.brent@utoronto.ca
Michael Brent, MD, FRCSC
About this study
Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Similar to IVTA, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. It is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after IVTA injection.
- Conditions
- Vitreoretinal Disease, Ocular Hypertension
- Being tested
- Prednisolone 1% topical eye drops
- Keywords
- Intravitreal triamcinolone acetonide, Side-effects, Ocular hypertension, Glaucoma, Prevention, Vitreoretinal diseases requiring IVTA for treatment
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone 1% topical eye dropsDrug
Prednisolone 1% 1gtt qid to the eye requiring IVTA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receive Prednisolone 1% 1gtt qid x 4 weeks. If the intraocular pressure (IOP) after the 4 weeks is > or equal to 21 mmHg, then IVTA will be withheld. If the IOP < 21mmHg, then patients will receive an injection of IVTA. Receives: Drug: Prednisolone 1% topical eye drops |
| 2 | No intervention | Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect a 60% or greater decrease of developing ocular hypertension (>20 mmHg) in the group of patients who received a trial of prednisolone 1% gtts x 4 weeks, compared the group who did not receive a trial of topical prednisolone.
Measured: Monthly for 6 months
Secondary outcomes (2)
Visual Acuity
Measured: Monthly for 6 months
Incidence of other complications (cataract, retinal detachment, endophthalmitis)
Measured: Monthly for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
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 Vitreoretinal DiseaseStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hotel Dieu Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Investigators
- Kenneth Eng, MD, FRCSC, Principal investigator, Sunnybrook Health Sciences CentreJeffery Gale, MD, FRCSC, Principal investigator, Hotel Dieu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744666
- Sponsor's protocol ID
- 07142008
- Acronym
- IVTA:PRE-TREAT
- Status last verified
- Aug 2009
- First submitted
- 29 Aug 2008
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Jonas JB, Kreissig I, Degenring R. Intraocular pressure after intravitreal injection of triamcinolone acetonide. Br J Ophthalmol. 2003 Jan;87(1):24-7. doi: 10.1136/bjo.87.1.24.
PubMed 12488256
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
- ClinicalTrials.gov ID
- NCT00744666
- Acronym / sponsor ID
- IVTA:PRE-TREAT / 07142008
- Conditions
- Vitreoretinal Disease, Ocular Hypertension
- Keywords
- Intravitreal triamcinolone acetonide, Side-effects, Ocular hypertension, Glaucoma, Prevention, Vitreoretinal diseases requiring IVTA for treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hotel Dieu HospitalUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 1 Sep 2008 (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.
Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Similar to IVTA, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. It is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after IVTA injection.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Prednisolone 1% topical eye dropsPatients receive Prednisolone 1% 1gtt qid x 4 weeks. If the intraocular pressure (IOP) after the 4 weeks is > or equal to 21 mmHg, then IVTA will be withheld. If the IOP < 21mmHg, then patients will receive an injection of IVTA. |
| 2 | No intervention | –Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment
Key exclusion criteria (8 listed)
- < 18 years old
- Pregnancy
- Breast feeding
- hx of uveitis
- hx of neovascularization of the iris or anterior chamber angle
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 |
|---|---|---|
| Prednisolone 1% topical eye dropsPrednisolone 1% 1gtt qid to the eye requiring IVTA | Drug | 1 |
Primary outcome
To detect a 60% or greater decrease of developing ocular hypertension (>20 mmHg) in the group of patients who received a trial of prednisolone 1% gtts x 4 weeks, compared the group who did not receive a trial of topical prednisolone.
Time frame: Monthly for 6 months
2 secondary outcomes
Visual Acuity
Time frame: Monthly for 6 months
Incidence of other complications (cataract, retinal detachment, endophthalmitis)
Time frame: Monthly for 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- Background: PubMed 12488256Jonas JB, Kreissig I, Degenring R. Intraocular pressure after intravitreal injection of triamcinolone acetonide. Br J Ophthalmol. 2003 Jan;87(1):24-7. doi: 10.1136/bjo.87.1.24.
Related trials for Vitreoretinal Disease
Recruiting
Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases
Vitreoretinal Disease
Recruiting
(CIRRUS-2023-1) CLINICAL CLIN Assessment of PathFinder 1.0 on the CIRRUS 6000 and the CIRRUS 5000
Epiretinal Membrane, Dry Age Related Macular Degeneration
Not yet recruitingObservational study
Wide Field OCTA in Ocular Diseases
Age - Related Macular Degeneration (AMD), Diabetic Macular Edema
RecruitingObservational study
Metabolomic Profile of Vitreoretinal Diseases: an NMR-Based Approach Using Vitreous.
Vitreoretinal Disease
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.
Kenneth Eng, MD, FRCSC principal investigator
Sunnybrook Health Sciences Centre
Jeffery Gale, MD, FRCSC principal investigator
Hotel Dieu Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone 1% topical eye drops in people with Vitreoretinal Disease and Ocular Hypertension, run by Hotel Dieu Hospital at 4 sites in Canada.
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 8 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 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Kenneth Eng, MD, FRCSC (416-480-4468, kt_eng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect a 60% or greater decrease of developing ocular hypertension (>20 mmHg) in the group of patients who received a trial of prednisolone 1% gtts x 4 weeks, compared the group who did not receive a trial of topical prednisolone. (time frame: Monthly for 6 months). 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 NCT00744666, 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 6 Aug 2009; AzTrials last refreshed its copy on 31 Oct 2026.