"Efficacy and Safety of Ranibizumab in Two Treat and Extend Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus"

PHASE3CompletedINTERVENTIONAL
Enrollment

373

Participants

Timeline

Start Date

September 30, 2010

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Diabetic Macular Edema
Interventions
DRUG

Ranibizumab

Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.

Trial Locations (68)

1083

Novartis Investigative Site, Budapest

1133

Novartis Investigative Site, Budapest

2333

Novartis Investigative Site, Leiden 2333 ZA

3000

Novartis Investigative Site, Leuven

3010

Novartis Investigative Site, Bern

3012

Novartis Investigative Site, Bern

4012

Novartis Investigative Site, Debrecen

4102

Novartis Investigative Site, Binningen

8063

Novartis Investigative Site, Zurich

8500

Novartis Investigative Site, Kortrijk

9000

Novartis Investigative Site, Ghent

9024

Novartis Investigative Site, Győr

15705

Novartis Investigative Site, Santiago de Compostela

20122

Novartis Investigative Site, Milan

20132

Novartis Investigative Site, Milan

20157

Novartis Investigative Site, Milan

21034

Novartis Investigative Site, Dijon

28040

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

35016

Novartis Investigative Site, Las Palmas de Gran Canaria

44093

Novartis Investigative Site, Nantes

46015

Novartis Investigative Site, Valencia

47011

Novartis Investigative Site, Valladolid

50134

Novartis Investigative Site, Florence

69003

Novartis Investigative Site, Lyon

75015

Novartis Investigative Site, Paris

75475

Novartis Investigative Site, Paris

87042

Novartis Investigative Site, Limoges

169 02

Novartis Investigative Site, Prague

505 05

Novartis Investigative Site, Hradec Králové

775 20

Novartis Investigative Site, Olomouc

301 00

Novartis Investigative Site, Pilsen

128 08

Novartis Investigative Site, Prague

33 000

Novartis Investigative Site, Bordeaux

59 037

Novartis Investigative Site, Lille

6 000

Novartis Investigative Site, Nice

GR-71110

Novartis Investigative Site, Heraklion Crete

152 31

Novartis Investigative Site, Athens

546 36

Novartis Investigative Site, Thessaloniki

Unknown

Novartis Investigative Site, Dublin

Novartis Investigative Site, Dublin

Novartis Investigative Site, Kilkenny

Novartis Investigative Site, Limerick

00133

Novartis Investigative Site, Roma

00198

Novartis Investigative Site, Roma

1081 HV

Novartis Investigative Site, Amsterdam

1105 AZ

Novartis Investigative Site, Amsterdam

6525 EX

Novartis Investigative Site, Nijmegen

3011 BH

Novartis Investigative Site, Rotterdam

43-300

Novartis Investigative Site, Bielsko-Biala

20-954

Novartis Investigative Site, Lublin

00-416

Novartis Investigative Site, Warsaw

50-367

Novartis Investigative Site, Wroclaw

4099-001

Novartis Investigative Site, Porto

3000-354

Novartis Investigative Site, Coimbra

1150-199

Novartis Investigative Site, Lisbon

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

03016

Novartis Investigative Site, Alicante

GU16 7UJ

Novartis Investigative Site, Frimley

AB25 2ZN

Novartis Investigative Site, Aberdeen

BS1 2LX

Novartis Investigative Site, Bristol

LS9 7TF

Novartis Investigative Site, Leeds

M13 9WL

Novartis Investigative Site, Manchester

NE1 4LP

Novartis Investigative Site, Newcastle upon Tyne

S10 2JF

Novartis Investigative Site, Sheffield

SO16 6YD

Novartis Investigative Site, Southampton

SR2 9HP

Novartis Investigative Site, Sunderland

WV10 0QP

Novartis Investigative Site, Wolverhampton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY