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

Ocular Hypertension Clinical Trial

— IVTA:PRE-TREAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00744666
• Other study ID #: 07142008
• Status: Recruiting
• Phase: Phase 4
• First received: August 29, 2008
• Last updated: August 4, 2009
• Start date: September 2008
• Est. completion date: July 2010

Study information

• Verified date: August 2009
• Source: Hotel Dieu Hospital
• Contact: Kenneth Eng, MD, FRCSC
• Phone: 416-480-4468
• Email: kt_eng[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Ocular Hypertension
• Vitreoretinal Disease

Intervention

Drug:
• Prednisolone 1% topical eye drops
Prednisolone 1% 1gtt qid to the eye requiring IVTA

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hotel Dieu Hospital	Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Jonas JB, Kreissig I, Degenring R. Intraocular pressure after intravitreal injection of triamcinolone acetonide. Br J Ophthalmol. 2003 Jan;87(1):24-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Monthly for 6 months	Yes
Secondary	Visual Acuity		Monthly for 6 months	Yes
Secondary	Incidence of other complications (cataract, retinal detachment, endophthalmitis)		Monthly for 6 months	Yes