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

NCT ID: NCT00744666

Last Updated: 2009-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vitreoretinal Disease Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Prednisolone 1% topical eye drops

Intervention Type DRUG

Prednisolone 1% 1gtt qid to the eye requiring IVTA

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prednisolone 1% topical eye drops

Prednisolone 1% 1gtt qid to the eye requiring IVTA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Hotel Dieu Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sunnybrook Health Sciences Centre

Principal Investigators

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Kenneth Eng, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Jeffery Gale, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu Hospital

Locations

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Hotel Dieu Hospital

Kingston, Ontario, Canada

Site Status RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status NOT_YET_RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Kenneth Eng, MD, FRCSC

Role: CONTACT

416-480-4468

Jeffery Gale, MD, FRCSC

Role: CONTACT

613-544-3400 ext. 3391

Facility Contacts

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Jeffery Gale, MD, FRCSC

Role: primary

613-544-3400 ext. 3391

Bernard Hurley, MD, FRCSC

Role: primary

(613) 737-8899 ext. 79422

Kenneth Eng, MD, FRCSC

Role: primary

416-480-4688

Brent Michael, MD, FRCSC

Role: primary

416-603-5444

References

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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.

Reference Type BACKGROUND
PMID: 12488256 (View on PubMed)

Other Identifiers

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07142008

Identifier Type: -

Identifier Source: org_study_id

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