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1 for Ocular Hypertension (IVTA:PRE-TREAT Trial)

Phase 4
Waitlist Available
Led By Kenneth Eng, MD, FRCSC
Research Sponsored by Hotel Dieu Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly for 6 months
Awards & highlights

IVTA:PRE-TREAT 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. 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.

Eligible Conditions
  • Ocular Hypertension
  • Vitreoretinal Disease

IVTA:PRE-TREAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

IVTA:PRE-TREAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly for 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Incidence of other complications (cataract, retinal detachment, endophthalmitis)
Visual Acuity

IVTA:PRE-TREAT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment1 Intervention
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.
Group II: 2Active Control1 Intervention
Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).

Find a Location

Who is running the clinical trial?

Hotel Dieu HospitalLead Sponsor
20 Previous Clinical Trials
19,928 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,551,372 Total Patients Enrolled
Kenneth Eng, MD, FRCSCPrincipal InvestigatorSunnybrook Health Sciences Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
2008. "IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00744666.
All > Mci
~4 spots leftby Apr 2025
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