Clinical trial NCT02259088: A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients
Official title: A 12-month, Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Dosed PRN in Subjects With Visual Impairment Due to Diabetic Macular Edema in Chinese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Visual Impairment
Keywords: DME
macular edema
vision impairment
Chinese
diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-10-08
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)

Detailed description: The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.

Eligibility criteria: Key Inclusion Criteria:

* Male or female Chinese patients ≥ 18 years of age with diabetes mellitus and with HbA1c ≤10.0%
* Stable medication for diabetes within 3 months prior to Visit 1
* Visual impairment due to DME with BCVA score between 78 and 39 letters as measured by ETDRS-like charts at 4 meters

Key Exclusion Criteria:

* Stroke or myocardial infarction less than 3 months prior to screening visit
* Uncontrolled hypertension
* Active ocular infection or intraocular inflammation in any eye
* Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
* Active proliferative diabetic retinopathy in study eye
* Use of other investigational drugs within 30 days and systemic anti-VEGF drugs within 6 months prior to baseline visit
* Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
* History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening

Primary outcomes:
measure: Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12
timeFrame: Baseline, Monthly from Month 1 through Month 12
Secondary outcomes:
measure: Mean Change From Baseline in BCVA (Letters) at Each Visit
timeFrame: Baseline, Monthly from Month 1 through Month 12
measure: Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
timeFrame: Baseline, Monthly from Month 1 through Month 12
measure: Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12
timeFrame: Baseline, Month 12
measure: Percentage of Patients With BCVA ≥ 73 Letters at Month 12
timeFrame: Month 12
measure: Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3
timeFrame: Monthly from Month 3 through Month 12
measure: Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward
timeFrame: Monthly from Month 3 through Month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shantou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Harbin
country: China
facility: Novartis Investigative Site
state: Heilongjiang
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Wuxi
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Qingdao
country: China
facility: Novartis Investigative Site
state: Shandong
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Wenzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: