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Completed

NCT Number: NCT00805064

Combined Triple Procedure in Retinal Vein Occlusion (RVO)

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).

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

triamcinolone and bevacizumab

Drug

Primary outcomes

  1. BCVA

    Time frame: day of exam

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Dec 9, 2008
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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