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Short-Term Effects of Intravitreal Bevacizumab and Trimacinolone in Patients With Diabetic Macular Edema

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University Hospital Inselspital, Berne
University of Bern
Information provided by: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00563940
  Purpose

Diabetic macular edema is a common complication of ocular diabetes mellitus and can cause blindness. Hypoxygenation of the retina stimulates tissue mediators, especially different subtypes of vascular endothelial growth factor (VEGF). VEGF is responsible for proliferation, extension and increased permeability of the vessels. The aim of our study was to examine the short-term effect of intravitreal bevacizumab (Avastin® 1.25 mg in 0.05 ml) and triamcinolone on visual acuity and central retinal thickness in patients with clinically significant diabetic macular edema (CSME).


Condition
Diabetic Macular Edema

Genetics Home Reference related topics:   X-linked juvenile retinoschisis   

MedlinePlus related topics:   Edema   

ChemIDplus related topics:   Bevacizumab   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, Prospective
Official Title:   Short-Term Effects of Intravitreal Bevacizumab and Trimacinolone in Patients With Diabetic Macular Edema

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Central retinal thickness [ Time Frame: 4, 8, 12, 24, 72, and 168 houres ]

Secondary Outcome Measures:
  • BCVA [ Time Frame: 4, 8, 12, 24, 72, and 168 hours ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   30
Study Start Date:   March 2007
Estimated Study Completion Date:   March 2008

Groups/Cohorts
1
2

  Eligibility
Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study Population

Patients with clinical significant macular edema


Criteria

Inclusion Criteria:

  • clinical significant macular edema

Exclusion Criteria:

  • retinal thickness < 250 µm
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563940

Locations
Switzerland
Klinik und Poliklinik für Augenheilkunde    
      Bern, Switzerland

Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern

Investigators
Principal Investigator:     Ute Wolf-Schnurrbusch, MD     University of Bern    
Study Director:     Sebastian Wolf, MD PhD     University of Bern    
  More Information

Study ID Numbers:   AUG 044/07, KEK E: 29-03-07
First Received:   November 26, 2007
Last Updated:   December 5, 2007
ClinicalTrials.gov Identifier:   NCT00563940
Health Authority:   Switzerland: Ethikkommision

Keywords provided by University Hospital Inselspital, Berne:
diabetic macular edema  
OCT  

Study placed in the following topic categories:
Signs and Symptoms
Macular Edema
Eye Diseases
Retinal Degeneration
Macular Degeneration
Edema
Bevacizumab
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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