Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema

This study has been completed.

First Received on November 26, 2007. Last Updated on September 5, 2011 History of Changes

Sponsor:	University Hospital Inselspital, Berne
Collaborator:	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

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Bevacizumab Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

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 ]

Enrollment:	30
Study Start Date:	March 2007
Study Completion Date:	February 2010

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00563940 History of Changes
Other Study ID Numbers:	AUG 044/07, KEK E: 29-03-07
Study First Received:	November 26, 2007
Last Updated:	September 5, 2011
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:

diabetic macular edema
OCT

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye 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 February 12, 2012