A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

384

Participants

Timeline

Start Date

November 5, 2014

Primary Completion Date

January 17, 2017

Study Completion Date

January 17, 2017

Conditions
Diabetic Macular EdemaVisual Impairment
Interventions
DRUG

Ranibizumab (RFB002)

Ranibizumab 0.5 mg/0.05 mL for intravitreal injection

PROCEDURE

Laser

Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines

DRUG

Sham injection

Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle

PROCEDURE

Sham laser

Imitation of an active laser

Trial Locations (28)

100034

Novartis Investigative Site, Beijing

100044

Novartis Investigative Site, Beijing

100050

Novartis Investigative Site, Beijing

100053

Novartis Investigative Site, Beijing

100176

Novartis Investigative Site, Beijing

100191

Novartis Investigative Site, Beijing

100730

Novartis Investigative Site, Beijing

Novartis Investigative Site, Beijing

150001

Novartis Investigative Site, Harbin

200080

Novartis Investigative Site, Shanghai

200092

Novartis Investigative Site, Shanghai

300020

Novartis Investigative Site, Tianjin

300070

Novartis Investigative Site, Tianjin

310003

Novartis Investigative Site, Hangzhou

310014

Novartis Investigative Site, Hangzhou

325027

Novartis Investigative Site, Wenzhou

330019

Novartis Investigative Site, Nanchang

400042

Novartis Investigative Site, Chongqing

410011

Novartis Investigative Site, Changsha

430022

Novartis Investigative Site, Wuhan

430070

Novartis Investigative Site, Wuhan

510060

Novartis Investigative Site, Guangzhou

510632

Novartis Investigative Site, Guangzhou

515041

Novartis Investigative Site, Shantou

610041

Novartis Investigative Site, Chengdu

710032

Novartis Investigative Site, Xi’an

2666000

Novartis Investigative Site, Qingdao

Unknown

Novartis Investigative Site, Wuxi

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY