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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: November 2013

Intervention(s) in this Clinical Trial

• Procedure: Grid Laser
  • ETDRS Grid Laser
• Procedure: Vitrectomy and 20 mg triamcinolone
  • Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Grid Laser
• Experimental: 2
  • Vitrectomy in combination with 20 mg triamcinolone

Primary Measures

• Visual acuity (ETDRS)
  • Time Frame: 12 and 36 Months
    Safety Issue?: No

Secondary Measures

• Retinal thickening measured on OCT.
  • Time Frame: 12 and 36 Months
    Safety Issue?: No

Inclusion Criteria:

• Macular edema secondary to BRVO
• Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart
• Duration no shorter than 3 months
• Duration no longer than 12 months

Exclusion Criteria:

• Proliferations in study eye
• Blod in vitreous cavity
• Previous fundus laser treatment
• BRVO with over 180˚ of ischemia on FA
• Age under 18
• Other eye condition which contribute to relevant loss of visual acuity

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stavanger University Hospital

Overall Clinical Trial Officials and Contacts

Johan Seland, PhD Study Director Stavanger University Hospital  

Overall Contact: Vegard Forsaa, MD  forsaa@gmail.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642226

Study ID Number: 3.2006.1159(REK)

ClinicalTrials.gov Identifier: NCT00642226

Health Authority: Norway: The National Committees for Research Ethics in Norway