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Combined Triple Procedure in Retinal Vein Occlusion (RVO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Koss, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00805064
First received: December 4, 2008
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Retinal Vein Occlusion
 Drug: triamcinolone and bevacizumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Retinal Vein Occlusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • BCVA [ Time Frame: day of exam ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2006
Study Completion Date: November 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ischemic CRVO
treatment was applied to this entity
 Drug: triamcinolone and bevacizumab
Active Comparator: non ischemic CRVO
treatment was applied to this entity
 Drug: triamcinolone and bevacizumab
Active Comparator: BRVO
treatment was applied to this entity
 Drug: triamcinolone and bevacizumab

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805064

Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Michael Koss, MD Department of VitreoRetinal Surgery ZAU JWGU
  More Information

No publications provided

Responsible Party: Michael Koss, PI, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00805064     History of Changes
Other Study ID Numbers: MK-KTRVO-2008
Study First Received: December 4, 2008
Last Updated: September 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 18, 2013