Safety and Efficacy of Ranibizumab in Diabetic Macular Edema

PHASE3TerminatedINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions
Visual Impairment Due to Diabetic Macular Edema
Interventions
PROCEDURE

Active laser photocoagulation

Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

DRUG

Sham injections

Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

DRUG

Ranibizumab 0.5 mg

Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Trial Locations (34)

Unknown

Novartis Investigative Site, Aschaffenburg

Novartis Investigative Site, Berlin

Novartis Investigative Site, Bonn

Novartis Investigative Site, Bremen

Novartis Investigative Site, Chemnitz

Novartis Investigative Site, Cologne

Novartis Investigative Site, Darmstadt

Novartis Investigative Site, Dessau

Novartis Investigative Site, Dortmund

Novartis Investigative Site, Dresden

Novartis Investigative Site, Eichstätt

Novartis Investigative Site, Essen

Novartis Investigative Site, Frankfurt

Novartis Investigative Site, Freiburg im Breisgau

Novartis Investigative Site, Giessen

Novartis Investigative Site, Hamburg

Novartis Investigative Site, Heidelberg

Novartis Investigative Site, Karlsruhe

Novartis Investigative Site, Kiel

Novartis Investigative Site, Landshut

Novartis Investigative Site, Leipzig

Novartis Investigative Site, Marburg

Novartis Investigative Site, Mühlheim

Novartis Investigative Site, München

Novartis Investigative Site, Münster

Novartis Investigative Site, Nuremberg

Novartis Investigative Site, Postdam

Novartis Investigative Site, Recklinghausen

Novartis Investigative Site, Regensburg

Novartis Investigative Site, Rosenheim

Novartis Investigative Site, Siegburg

Novartis Investigative Site, Stuttgart

Novartis Investigative Site, Ulm

Novartis Investigative Site, Würzburg

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY