NCT00563940

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

2.9 years

First QC Date

November 26, 2007

Last Update Submit

July 4, 2019

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edemaOCT

Outcome Measures

Primary Outcomes (1)

  • Central retinal thickness

    4, 8, 12, 24, 72, and 168 hours

Secondary Outcomes (1)

  • BCVA

    4, 8, 12, 24, 72, and 168 hours

Study Arms (2)

1

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with clinical significant macular edema

You may qualify if:

  • clinical significant macular edema

You may not qualify if:

  • retinal thickness \< 250 µm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik für Augenheilkunde

Bern, Switzerland

Location

Study Officials

  • Ute Wolf-Schnurrbusch, MD

    University of Bern

    PRINCIPAL INVESTIGATOR

  • Sebastian Wolf, MD PhD

    University of Bern

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 27, 2007

Study Start

March 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

CH(1)