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Combined Triple Procedure in Retinal Vein Occlusion (RVO)

Phase 3
Completed
Conditions
Retinal Vein Occlusion
Interventions
Registration Number
NCT00805064
Lead Sponsor
Johann Wolfgang Goethe University Hospital
Brief Summary

The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).

Detailed Description

This prospective study of a case series was conducted in 47 patients (n = 47 eyes; f/m: 21/26; mean age: 66.6 years) with ischemic central RVO (CRVO) (n = 15), non-ischemic CRVO (n = 7), or branch RVO (BRVO) (n = 25). A core pars plana vitrectomy with aspiration of 1.5 ml vitreous and infusion of balanced salt solution (BSS; 1 ml), 8 mg (0.4 ml) triamcinolone, and 1.25 mg (0.1 ml) bevacizumab was performed with a single sutureless sclerotomy and a 23 gauge probe tip. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Ischemic central RVO (CRVO)
  • Non-ischemic CRVO
  • Branch RVO (BRVO)
Exclusion Criteria
  • Visual deterioration due to acute or chronic inflammation
  • Post trauma
  • Macular edema of other origin
  • Intravitreal drug treatment within last 4 months

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ischemic CRVOtriamcinolone and bevacizumabtreatment was applied to this entity
non ischemic CRVOtriamcinolone and bevacizumabtreatment was applied to this entity
BRVOtriamcinolone and bevacizumabtreatment was applied to this entity
Primary Outcome Measures
NameTimeMethod
BCVAday of exam
Secondary Outcome Measures
NameTimeMethod
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