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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00744666
Recruitment Status : Unknown
Verified August 2009 by Hotel Dieu Hospital.
Recruitment status was:  Recruiting
First Posted : September 1, 2008
Last Update Posted : August 6, 2009
Sunnybrook Health Sciences Centre
Information provided by:
Hotel Dieu Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Vitreoretinal Disease Ocular Hypertension Drug: Prednisolone 1% topical eye drops Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
Study Start Date : September 2008
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : July 2010

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).

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: Monthly for 6 months ]
  2. Incidence of other complications (cataract, retinal detachment, endophthalmitis) [ Time Frame: Monthly for 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00744666

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Contact: Kenneth Eng, MD, FRCSC 416-480-4468
Contact: Jeffery Gale, MD, FRCSC 613-544-3400 ext 3391

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Canada, Ontario
Hotel Dieu Hospital Recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: Jeffery Gale, MD, FRCSC    613-544-3400 ext 3391   
Sub-Investigator: Christina Leung, MD         
Principal Investigator: Jeffery Gale, MD, FRCSC         
Sub-Investigator: Delan Jinapriya, MD, FRCSC         
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Bernard Hurley, MD, FRCSC    (613) 737-8899 ext 79422   
Principal Investigator: Bernard Hurley, MD, FRCSC         
Sub-Investigator: Sylvia Chen, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Kenneth Eng, MD, FRCSC    416-480-4688   
Sub-Investigator: Peter Kertes, MD, FRCSC         
Sub-Investigator: Carol Schwartz, MD, FRCSC         
Sub-Investigator: Daniel Weisbrod, MD, FRCSC         
Principal Investigator: Kenneth Eng, MD, FRCSC         
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Brent Michael, MD, FRCSC    416-603-5444   
Principal Investigator: Michael Brent, MD, FRCSC         
Sub-Investigator: Chirag Shah, MD, FRCSC         
Sub-Investigator: Patrick Santiago, MD, FRCSC         
Sponsors and Collaborators
Hotel Dieu Hospital
Sunnybrook Health Sciences Centre
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Principal Investigator: Kenneth Eng, MD, FRCSC Sunnybrook Health Sciences Centre
Principal Investigator: Jeffery Gale, MD, FRCSC Hotel Dieu Hospital

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Responsible Party: Dr. Kenneth Eng, Sunnybrook Health Sciences Centre Identifier: NCT00744666     History of Changes
Other Study ID Numbers: 07142008
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009
Keywords provided by Hotel Dieu Hospital:
Intravitreal triamcinolone acetonide
Ocular hypertension
Vitreoretinal diseases requiring IVTA for treatment
Additional relevant MeSH terms:
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Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Triamcinolone Acetonide
Triamcinolone hexacetonide
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Immunosuppressive Agents