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

Primary Purpose

Vitreoretinal Disease, Ocular Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Prednisolone 1% topical eye drops
Sponsored by
Hotel Dieu Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Vitreoretinal Disease focused on measuring Intravitreal triamcinolone acetonide, Side-effects, Ocular hypertension, Glaucoma, Prevention, Vitreoretinal diseases requiring IVTA for treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hotel Dieu HospitalRecruiting
  • The Ottawa Hospital
  • Sunnybrook Health Sciences CentreRecruiting
  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

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.

Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).

Outcomes

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.

Secondary Outcome Measures

Visual Acuity
Incidence of other complications (cataract, retinal detachment, endophthalmitis)

Full Information

First Posted
August 29, 2008
Last Updated
August 4, 2009
Sponsor
Hotel Dieu Hospital
Collaborators
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00744666
Brief Title
IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
Acronym
IVTA:PRE-TREAT
Official Title
IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hotel Dieu Hospital
Collaborators
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreoretinal Disease, Ocular Hypertension
Keywords
Intravitreal triamcinolone acetonide, Side-effects, Ocular hypertension, Glaucoma, Prevention, Vitreoretinal diseases requiring IVTA for treatment

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
No Intervention
Arm Description
Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).
Intervention Type
Drug
Intervention Name(s)
Prednisolone 1% topical eye drops
Intervention Description
Prednisolone 1% 1gtt qid to the eye requiring IVTA
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Visual Acuity
Time Frame
Monthly for 6 months
Title
Incidence of other complications (cataract, retinal detachment, endophthalmitis)
Time Frame
Monthly for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth Eng, MD, FRCSC
Phone
416-480-4468
Email
kt_eng@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffery Gale, MD, FRCSC
Phone
613-544-3400
Ext
3391
Email
jeffgaleuwo@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Eng, MD, FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffery Gale, MD, FRCSC
Organizational Affiliation
Hotel Dieu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffery Gale, MD, FRCSC
Phone
613-544-3400
Ext
3391
Email
jeffgaleuwo@yahoo.com
First Name & Middle Initial & Last Name & Degree
Christina Leung, MD
First Name & Middle Initial & Last Name & Degree
Jeffery Gale, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Delan Jinapriya, MD, FRCSC
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard Hurley, MD, FRCSC
Phone
(613) 737-8899
Ext
79422
Email
bhurley@Ottawahospital.on.ca
First Name & Middle Initial & Last Name & Degree
Bernard Hurley, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Sylvia Chen, MD
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Eng, MD, FRCSC
Phone
416-480-4688
Email
kt_eng@hotmail.com
First Name & Middle Initial & Last Name & Degree
Peter Kertes, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Carol Schwartz, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Daniel Weisbrod, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Kenneth Eng, MD, FRCSC
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brent Michael, MD, FRCSC
Phone
416-603-5444
Email
mh.brent@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Michael Brent, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Chirag Shah, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Patrick Santiago, MD, FRCSC

12. IPD Sharing Statement

Citations:
PubMed Identifier
12488256
Citation
Jonas JB, Kreissig I, Degenring R. Intraocular pressure after intravitreal injection of triamcinolone acetonide. Br J Ophthalmol. 2003 Jan;87(1):24-7. doi: 10.1136/bjo.87.1.24.
Results Reference
background

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IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids

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