IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-Pressure by Tracking Elevations After Topical Steroids - Full Text View

Sponsors and Collaborators:	Hotel Dieu Hospital Sunnybrook Health Sciences Centre
Information provided by:	Hotel Dieu Hospital
ClinicalTrials.gov Identifier:	NCT00744666

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 IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-Pressure by Tracking Elevations After Topical Steroids

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 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: No Intervention 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
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
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:

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

Responsible Party:	Sunnybrook Health Sciences Centre ( Dr. Kenneth Eng )
Study ID Numbers:	07142008
Study First Received:	August 29, 2008
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00744666
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

Study placed in the following topic categories:

Methylprednisolone
Eye Diseases
Vascular Diseases
Methylprednisolone acetate
Triamcinolone diacetate
Prednisolone acetate
Tetrahydrozoline
Triamcinolone hexacetonide

Triamcinolone Acetonide
Glaucoma
Triamcinolone
Prednisolone
Ocular Hypertension
Hypertension
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Enzyme Inhibitors
Immunosuppressive Agents

Protective Agents
Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009