NCT00989989 - Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema | Biotech Hunter

Enrollment

396

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions

Diabetic Macular Edema

Interventions

DRUG

Ranibizumab

Ranibizumab 0.5 mg intravitreal injection at day 1, month 1 and month 2. If stable vision not reached at month 3, one injection per month continued until stable vision was reached. Intravitreal injections re-initiated if needed.

PROCEDURE

Laser photocoagulation

Active laser treatment administered at day 1. Subsequent laser treatments administered if needed at intervals no shorter than 3 months from previous laser treatment.

DRUG

Sham ranibizumab

Sham intravitreal injections to ranibizumab at day 1, month 1 and month 2. Intravitreal injections re-initiated if needed.

PROCEDURE

Sham laser photocoagulation

Sham laser treatment administered at day 1.

Trial Locations (35)

Unknown

Novartis Investigative Site, Beijing

Novartis Investigative Site, Changsha

Novartis Investigative Site, Chengdu

Novartis Investigative Site, Chongqing

Novartis Investigative Site, Guangzhou

Novartis Investigative Site, Hangzhou

Novartis Investigational Site, Shanghai

Novartis Investigative Site, Wenzhou

Novartis Investigative Site, Xi'an

Novartis Investigative Site, Hong Kong

Novartis Investigative Site, Chiba

Novartis Investigative Site, Chiyoda-ku

Novartis Investigative Site, Chūōku

Novartis Investigative Site, Fukuoka

Novartis Investigative Site, Fukushima

Novartis Investigative Site, Hirakata

Novartis Investigative Site, Kita-gun

Novartis Investigative Site, Kobe

Novartis Investigative Site, Kyoto

Novartis Investigative Site, Mitaka

Novartis Investigative Site, Nagoya

Novartis Investigative Site, Osaka

Novartis Investigative Site, Ōtsu

Novartis Investigative Site, Shimotsuke

Novartis Investigative Site, Shinjuku-ku

Novartis Investigative Site, Suita

Novartis Investigative Site, Toyko

Novartis Investigative Site, Urayasu

Novartis Investigative Site, Wakayama

Novartis Investigative Site, Yamagata

Novartis Investigative Site, Singapore

Novartis Investigative Site, Seoul

Novartis Investigative Site, Kaohsiung City

Novartis Investigative Site, Linkou District

Novartis Investigative Site, Taipei