Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)

PHASE3CompletedINTERVENTIONAL
Enrollment

244

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Visual ImpairmentMacular EdemaBranch Retinal Vein Occlusion
Interventions
DRUG

Ranibizumab

Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split

OTHER

Dexamethasone Implant

Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.

OTHER

Sham injection

Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration

Trial Locations (66)

1083

Novartis Investigative Site, Budapest

4004

Novartis Investigative Site, Debrecen

10713

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

20246

Novartis Investigative Site, Hamburg

22417

Novartis Investigative Site, Hamburg

24105

Novartis Investigative Site, Kiel

28209

Novartis Investigative Site, Bremen

32427

Novartis Investigative Site, Minden

35039

Novartis Investigative Site, Marburg

37075

Novartis Investigative Site, Göttingen

38442

Novartis Investigative Site, Wolfsburg

40212

Novartis Investigative Site, Düsseldorf

40225

Novartis Investigative Site, Düsseldorf

44791

Novartis Investigative Site, Bochum

45468

Novartis Investigative Site, Mülheim

45657

Novartis Investigative Site, Recklinghausen

48145

Novartis Investigative Site, Münster

48149

Novartis Investigative Site, Münster

49215

Novartis Investigative Site, Bad Rothenfelde

50935

Novartis Investigative Site, Cologne

53127

Novartis Investigative Site, Bonn

58097

Novartis Investigative Site, Hagen

60318

Novartis Investigative Site, Frankfurt

64298

Novartis Investigative Site, Darmstadt

66280

Novartis Investigative Site, Sulzbach

66421

Novartis Investigative Site, Homburg

67063

Novartis Investigative Site, Ludwigshafen

72076

Novartis Investigative Site, Tübingen

76133

Novartis Investigative Site, Karlsruhe

76199

Novartis Investigative Site, Karlsruhe

79106

Novartis Investigative Site, Freiburg I. Br

80336

Novartis Investigative Site, Munich

81675

Novartis Investigative Site, München

85049

Novartis Investigative Site, Ingolstadt

85155

Novartis Investigative Site, Augsburg

89075

Novartis Investigative Site, Ulm

93042

Novartis Investigative Site, Regensburg

97080

Novartis Investigative Site, Würzburg

100 34

Novartis Investigative Site, Prague

04103

Novartis Investigative Site, Leipzig

09116

Novartis Investigative Site, Chemnitz

01257

Novartis Investigative Site, Dresden

08371

Novartis Investigative Site, Glauchau

06114

Novartis Investigative Site, Halle

H-6720

Novartis Investigative Site, Szeged

Unknown

Novartis Investigative Site, Bydgoszcz

41-902

Novartis Investigative Site, Bytom

B152WB

Novartis Investigative Site, Birmingham

B18 7QU

Novartis Investigative Site, Birmingham

BD9 6RJ

Novartis Investigative Site, Bradford

CW14QJ

Novartis Investigative Site, Cheshire

CO3 3NB

Novartis Investigative Site, Colchester

DE22 3NE

Novartis Investigative Site, Derby

GL1 3NN

Novartis Investigative Site, Gloucester

GU2 5XX

Novartis Investigative Site, Guildford, Surrey

CT1 3NG

Novartis Investigative Site, Kent

LS9 7TF

Novartis Investigative Site, Leeds

SE1 7EH

Novartis Investigative Site, London

M13 9WH

Novartis Investigative Site, Manchester

TS4 3BW

Novartis Investigative Site, Middlesbrough

NG7 2UH

Novartis Investigative Site, Nottingham

PO6 3LY

Novartis Investigative Site, Portsmouth

CV22 5PX

Novartis Investigative Site, Rugby

SS0 0RY

Novartis Investigative Site, Westcliff-on-Sea

YO31 8HE

Novartis Investigative Site, York

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY