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

This study is ongoing, but not recruiting participants.

First Received: November 26, 2007 Last Updated: December 5, 2007 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:	Case-Only, Prospective
Official Title:	Short-Term Effects of Intravitreal Bevacizumab and Trimacinolone in Patients With Diabetic Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Bevacizumab

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 ]

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

No publications provided

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

Keywords provided by University Hospital Inselspital, Berne:

diabetic macular edema
OCT

Additional relevant MeSH terms:

Antineoplastic Agents
Eye Diseases
Growth Substances
Physiological Effects of Drugs
Edema
Macular Degeneration
Retinal Degeneration
Bevacizumab

Angiogenesis Inhibitors
Pharmacologic Actions
Macular Edema
Signs and Symptoms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases

ClinicalTrials.gov processed this record on November 30, 2009