Skip to main content
Clinical Trials/NCT00805064
NCT00805064
Completed
Phase 3

Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Retinal Vein Occlusion

Johann Wolfgang Goethe University Hospital0 sites40 target enrollmentJanuary 2006

Overview

Phase
Phase 3
Intervention
triamcinolone and bevacizumab
Conditions
Retinal Vein Occlusion
Sponsor
Johann Wolfgang Goethe University Hospital
Enrollment
40
Primary Endpoint
BCVA
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
November 2008
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Johann Wolfgang Goethe University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Michael Koss

PI

Johann Wolfgang Goethe University Hospital

Eligibility Criteria

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

Arms & Interventions

ischemic CRVO

treatment was applied to this entity

Intervention: triamcinolone and bevacizumab

non ischemic CRVO

treatment was applied to this entity

Intervention: triamcinolone and bevacizumab

BRVO

treatment was applied to this entity

Intervention: triamcinolone and bevacizumab

Outcomes

Primary Outcomes

BCVA

Time Frame: day of exam

Similar Trials