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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hotel Dieu Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by:
Hotel Dieu Hospital
ClinicalTrials.gov Identifier:
NCT00744666
First received: August 29, 2008
Last updated: August 4, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Vitreoretinal Disease
Ocular Hypertension
Drug: Prednisolone 1% topical eye drops
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids

Resource links provided by NLM:


Further study details as provided by Hotel Dieu Hospital:

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. [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: Yes ]
  • Incidence of other complications (cataract, retinal detachment, endophthalmitis) [ Time Frame: Monthly for 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: September 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744666

Contacts
Contact: Kenneth Eng, MD, FRCSC 416-480-4468 kt_eng@hotmail.com
Contact: Jeffery Gale, MD, FRCSC 613-544-3400 ext 3391 jeffgaleuwo@yahoo.com

Locations
Canada, Ontario
Hotel Dieu Hospital Recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: Jeffery Gale, MD, FRCSC    613-544-3400 ext 3391    jeffgaleuwo@yahoo.com   
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    bhurley@Ottawahospital.on.ca   
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    kt_eng@hotmail.com   
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    mh.brent@utoronto.ca   
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
Investigators
Principal Investigator: Kenneth Eng, MD, FRCSC Sunnybrook Health Sciences Centre
Principal Investigator: Jeffery Gale, MD, FRCSC Hotel Dieu Hospital
  More Information

Publications:
Responsible Party: Dr. Kenneth Eng, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00744666     History of Changes
Other Study ID Numbers: 07142008
Study First Received: August 29, 2008
Last Updated: August 4, 2009
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Hotel Dieu Hospital:
Intravitreal triamcinolone acetonide
Side-effects
Ocular hypertension
Glaucoma
Prevention
Vitreoretinal diseases requiring IVTA for treatment

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Triamcinolone hexacetonide
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Triamcinolone
Triamcinolone Acetonide
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014