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NCT00642226 Clinical Trial

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

Macular Edema Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00642226
Other study ID # 3.2006.1159(REK)
Secondary ID 3.2006.115914836
Status Terminated
Phase Phase 3
First received March 19, 2008
Last updated January 3, 2014
Start date November 2006
Est. completion date November 2013

Study information
Verified date January 2014
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 34
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Norway Stavanger University Hospital, Department of Ophthalmology Stavanger

Sponsors (1)
Lead Sponsor Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity (ETDRS) 12 and 36 Months No
Secondary Retinal thickening measured on OCT. 12 and 36 Months No
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