Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

Phase 3

Terminated

• Conditions: Macular Edema; Branch Retinal Vein Occlusion
• Interventions: Procedure: Grid Laser; Procedure: Vitrectomy and 20 mg triamcinolone

• Registration Number: NCT00642226
• Lead Sponsor: Helse Stavanger HF

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-24
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Grid Laser	Grid Laser
2	Vitrectomy and 20 mg triamcinolone	Vitrectomy in combination with 20 mg triamcinolone

Primary Outcome Measures

Name	Time	Method
Visual acuity (ETDRS)	12 and 36 Months

Secondary Outcome Measures

Name	Time	Method
Retinal thickening measured on OCT.	12 and 36 Months

Trial Locations

Locations (1)

Stavanger University Hospital, Department of Ophthalmology; 🇳🇴 Stavanger, Norway