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
Recruitment status was Recruiting
Sponsor:
Hotel Dieu Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Triamcinolone diacetate
Triamcinolone acetonide
Methylprednisolone
Triamcinolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Triamcinolone hexacetonide
U.S. FDA Resources
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 June 18, 2013