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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
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
Triamcinolone hexacetonide
Prednisolone acetate
Methylprednisolone acetate
Triamcinolone
Triamcinolone Acetonide
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 09, 2016