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

July 4, 2019 updated by: University Hospital Inselspital, Berne

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).

Study Overview

Status

Completed

Conditions

Diabetic Macular Edema

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- - Bern, Switzerland
    - Klinik und Poliklinik für Augenheilkunde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with clinical significant macular edema

Description

Inclusion Criteria:

clinical significant macular edema

Exclusion Criteria:

retinal thickness < 250 µm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1
2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Central retinal thickness Time Frame: 4, 8, 12, 24, 72, and 168 hours	4, 8, 12, 24, 72, and 168 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
BCVA Time Frame: 4, 8, 12, 24, 72, and 168 hours	4, 8, 12, 24, 72, and 168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

University of Bern

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria