A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema

PHASE2TerminatedINTERVENTIONAL
Enrollment

199

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Macular Edema, Diabetic
Interventions
DRUG

Ranibizumab

"Intravitreal Injection supplied as:~* 10 mg/mL in a 0.2 mL vial with instructions on preparation and administration of the 0.5 mg (0.05 mL) dose.~* 6 mg/mL in a single use vial with instructions on preparation and administration of the 0.3 mg (0.05 mL) dose.~* Adminstered once a month for 12 weeks"

DRUG

Placebo

"Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817.~Dose is 4 tablets each day for 12 weeks"

DRUG

PF-04634817

Four 50mg tablets PF-04634817 once a day for 12 weeks.

DRUG

Masked Sham Therapy

Empty, needle-less syringe is used by the unmasked team once a month.

Trial Locations (63)

1083

Semmelweis Egyetem, Szemészeti Klinika, Budapest

1106

Bajcsy-Zsilinszky Korhaz, Szemeszet, Budapest

1133

Budapest Retina Associates Kft., Budapest

1612

MC Comac Medical, Sofia

4032

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Szemklinika, Debrecen

7621

Ganglion Orvosi Kozpont, Pécs

8200

Csolnoky Ferenc Korhaz, Szemeszeti Osztaly, Veszprém

10034

Fakultni nemocnice Kralovske Vinohrady, Oftalmologicka klinika, Prague

Fakultni nemocnice Kralovske Vinohrady, Ustavni lekarna, Prague

12200

Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin

15122

Associates in Ophthalmology Ltd, West Mifflin

15213

Retina Vitreous Consultants, Pittsburgh

28210

Charlotte Eye Ear Nose and Throat Associates PA, Charlotte

30909

Southeast Retina Center, PC, Augusta

33136

Bascom Palmer Eye Institute, Miami

33324

Fort Lauderdale Eye Institute, Plantation

33880

Center for Retina and Macular Disease, Winter Haven

37075

Universitaetsmedizin Goettingen, Göttingen

44122

Retina Associates of Cleveland, Inc., Cleveland

44281

Meir Medical Center, Kfar Saba

44505

Retina Associates of Cleveland, Youngstown

46290

Midwest Eye Institute, Indianapolis

48073

Wm Beaumont Medical Office Building, Royal Oak

48145

Augenärzte am St. Franziskus-Hospital, Münster

48159

Universitaetsklinikum Muenster, Münster

49100

Rabin Medical Center, Beilinson Hospital, Petah Tikva

49202

TLC Eyecare & Laser Center, Jackson

50005

Fakultní nemocnice Hradec Králové, Nemocnicni lekarna, Hradec Králové

55131

Universitatsmedizin Mainz, Mainz

57701

Black Hills Regional Eye Institute, Rapid City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

66280

Knappschaftsklinikum GmbH, Sulzbach

70852

Fakultni nemocnice Ostrava, lekarna, Ostrava - Poruba

Fakultni nemocnice Ostrava, Ocni klinika, Ostrava - Poruba

72076

Universitatsklinikum Tubingen, Tübingen

73104

Dean McGee Eye Institute, Oklahoma City

University of Oklahoma -OU Physicians, Oklahoma City

76100

Kaplan Medical Center, Rehovot

77030

Retina Consultants of Houston, PA, Houston

78240

Medical Center Ophthalmology Associates, San Antonio

78705

Brain B.Berger,MD,PA, Austin

Retina Research Center, Austin

84107

Rocky Mountain Retina Consultants, Salt Lake City

85014

Retina Research Institute, LLC, Phoenix

Retinal Consultants of Arizona, Phoenix

85018

Sunny View Medical Center, Phoenix

85027

Premier Research Group Limited, Phoenix

85704

Retina Centers, P.C., Tucson

90211

Retina Vitreous Associates Medical Group, Beverly Hills

90603

American Institute of Research (Administrative Only), Whittier

91007

Retina Institute of California, Arcadia

91120

Hadassah Medical Organization, Hadassah Medical Center, Ein Karem, Jerusalem

92211

Southern California Desert Retina Consultants, Palm Desert

92653

Retina Associates of Orange County, Laguna Hills

93053

Universitätsklinikum Regensburg, Regensburg

95008

Retinal Diagnostic Center, Campbell

06320

New England Retina Associates, New London

02111

Tufts Medical Center, Boston

500 05

Fakultní nemocnice Hradec Králové, Ocni klinika, Hradec Králové

MD-2025

Spitalul Clinic Republican, Chisinau

50-367

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza Radeckiego We Wrocławiu, Klinika Okulistyki, Wroclaw

010719

Med Life SA, Sectia Oftalmologie, Bucharest

020475

"Institutul National de Diabet, Nutritie si Boli Metabolice N.C.Paulescu", Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY