A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study

PHASE3CompletedINTERVENTIONAL
Enrollment

345

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2012

Conditions
Diabetic Macular Edema
Interventions
DRUG

Ranibizumab

0.5 mg ranibizumab administered by intravitreal injection.

PROCEDURE

Laser

Laser photocoagulation treatment

PROCEDURE

Sham laser

Sham to laser procedure.

DRUG

Sham to ranibizumab

Sham to ranibizumab administered as an intravitreal injection.

Trial Locations (13)

Unknown

Novartis Investigative Site, Melbourne

Novartis Investigative Site, Leuven

Novartis Investigative Site, Ontario

Novartis Investigative Site, Paris

Novartis Investigative Site, Düsseldorf

Novartis Investigative Site, Athens

Novartis Investigative Site, Budapest

Novartis Investigative Site, Florence

Novartis Investigative Site, Amsterdam

Novartis Investigative Site, Barcelona

Novartis Investigational Site, Zurich

Novartis Investigative Site, Ankara

Novartis Investigative Site, Upton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY