NCT01580020 - Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO | Biotech Hunter

Enrollment

175

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions

Retinal Vein Occlusion

Interventions

BIOLOGICAL

RFB002

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. Each vial contained ranibizumab in an aqueous solution (pH 5.5) with histidine, trehalose and polysorbate 20.

DRUG

Dexamethasone

Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone; 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. Dexamethasone had to be stored according to label instructions and it had to be kept in a secure locked facility

Trial Locations (37)

10713

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

20246

Novartis Investigative Site, Hamburg

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

45468

Novartis Investigative Site, Mülheim

45657

Novartis Investigative Site, Recklinghausen

48145

Novartis Investigative Site, Münster

48149

Novartis Investigative Site, Münster

49214

Novartis Investigative Site, Bad Rothenfelde

50935

Novartis Investigative Site, Cologne

53127

Novartis Investigative Site, Bonn

60318

Novartis Investigative Site, Frankfurt

64297

Novartis Investigative Site, Darmstadt

66280

Novartis Investigative Site, Sulzbach

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, München

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

04103

Novartis Investigative Site, Leipzig

09113

Novartis Investigative Site, Chemnitz

01307

Novartis Investigative Site, Dresden

08371

Novartis Investigative Site, Glauchau

06114

Novartis Investigative Site, Halle