IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids (IVTA:PRE-TREAT)

August 4, 2009 updated by: Hotel Dieu Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Recruiting
        • Hotel Dieu Hospital
        • Contact:
        • Sub-Investigator:
          • Christina Leung, MD
        • Principal Investigator:
          • Jeffery Gale, MD, FRCSC
        • Sub-Investigator:
          • Delan Jinapriya, MD, FRCSC
      • Ottawa, Ontario, Canada, K1H 8L6
        • Not yet recruiting
        • The Ottawa Hospital
        • Contact:
        • Principal Investigator:
          • Bernard Hurley, MD, FRCSC
        • Sub-Investigator:
          • Sylvia Chen, MD
      • Toronto, Ontario, Canada, M5T 2S8
        • Not yet recruiting
        • Toronto Western Hospital
        • Contact:
        • Principal Investigator:
          • Michael Brent, MD, FRCSC
        • Sub-Investigator:
          • Chirag Shah, MD, FRCSC
        • Sub-Investigator:
          • Patrick Santiago, MD, FRCSC
      • Toronto, Ontario, Canada, M4N3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Sub-Investigator:
          • Peter Kertes, MD, FRCSC
        • Sub-Investigator:
          • Carol Schwartz, MD, FRCSC
        • Sub-Investigator:
          • Daniel Weisbrod, MD, FRCSC
        • Principal Investigator:
          • Kenneth Eng, MD, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment

Exclusion Criteria:

  • < 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
Drug: Prednisolone 1% topical eye drops
Prednisolone 1% 1gtt qid to the eye requiring IVTA
No Intervention: 2
Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Monthly for 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Acuity
Time Frame: Monthly for 6 months
Monthly for 6 months
Incidence of other complications (cataract, retinal detachment, endophthalmitis)
Time Frame: Monthly for 6 months
Monthly for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hotel Dieu Hospital

Collaborators

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Kenneth Eng, MD, FRCSC, Sunnybrook Health Sciences Centre
  • Principal Investigator: Jeffery Gale, MD, FRCSC, Hotel Dieu Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 4, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07142008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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