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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
674 Previous Clinical Trials
1,565,785 Total Patients Enrolled
Kenneth Eng, MD, FRCSCPrincipal InvestigatorSunnybrook Health Sciences Centre
~4 spots leftby Nov 2025