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Sponsored by: |
Stavanger University Hospital |
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Information provided by: | Stavanger University Hospital |
ClinicalTrials.gov Identifier: | NCT00642226 |
The purpose of this study is to determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion.
Condition | Intervention | Phase |
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Branch Retinal Vein Occlusion Macular Edema |
Procedure: Grid Laser Procedure: Vitrectomy and 20 mg triamcinolone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A Randomized Study Comparing Combined Vitrectomy and Triamcinolone to Laser Grid in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO) |
Estimated Enrollment: | 34 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2013 |
Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Grid Laser
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Procedure: Grid Laser
ETDRS Grid Laser
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2: Experimental
Vitrectomy in combination with 20 mg triamcinolone
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Procedure: Vitrectomy and 20 mg triamcinolone
Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vegard Forsaa, MD | forsaa@gmail.com | |
Contact: Johan Seland, PhD | jsel@sus.no |
Norway | |
Stavanger University Hospital, Department of Ophthalmology | Recruiting |
Stavanger, Norway, 4018 | |
Contact: Rune Hapnes, MD +47 99 44 13 29 hap@sus.no | |
Principal Investigator: Vegard Forsaa, MD |
Study Director: | Johan Seland, PhD | Stavanger University Hospital |
Responsible Party: | Stavanger University Hospital ( Vegard Forsaa/MD ) |
Study ID Numbers: | 3.2006.1159(REK), 3.2006.1159(REK), 14836(NSD) |
Study First Received: | March 19, 2008 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00642226 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services |
Branch Retinal Vein Occlusion BRVO Macular Edema Triamcinolone Vitrectomy |
Eye Diseases Temazepam Vascular Diseases Retinal Degeneration Edema Macular Degeneration Triamcinolone diacetate Thrombosis Triamcinolone hexacetonide Macular Edema |
Signs and Symptoms Embolism and Thrombosis Triamcinolone Acetonide Embolism Retinal Vein Occlusion Triamcinolone Neoplasm Metastasis Venous Thrombosis Retinal Diseases Retinal degeneration |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Enzyme Inhibitors Cardiovascular Diseases Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions |