Clinical trial NCT01775124: Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)
Official title: A 24-month, Randomized, Double-masked, Controlled, Multicenter Study Evaluating the Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With Neovascular Age Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Macular degeneration,
age-related macular degeneration (ARMD),
vision loss,
macula damage,
retina damage,
dry macular degeneration,
wet macular degeneration,
AMD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 332
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.


Eligibility criteria: Key Inclusion criteria:

* Patients with visual impairment due to neovascular AMD
* A qualifying vision score at study entry Key Exclusion criteria
* Active infection or inflammation either eye at study entry
* Uncontrolled glaucoma in either eye
* Any disorder in the study eye which may affect vision
* Use of any systemic anti-vascular endothelial growth factor (VEGF)-drugs within 3 months prior to study entry
* Previous treatment of the study eye for wet AMD
* Any surgery in the study eye 3 months prior to or planned with 6 month after study entry

Primary outcomes:
measure: Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12
timeFrame: Month 3 to month 4 through Month 12
Secondary outcomes:
measure: Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24
timeFrame: Month 3 to month 4 through Month 24
measure: Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24
timeFrame: Baseline to Month 24
measure: Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
timeFrame: Baseline to 24 months
measure: Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
timeFrame: Baseline to Month 24
measure: Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
timeFrame: Baseline to Month 24
measure: Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More
timeFrame: Month 12 and 24
measure: Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
timeFrame: Baseline to Month 24
measure: Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24
timeFrame: up to month 24
measure: Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12
timeFrame: prior to month 12
measure: Duration of Active Treatment Phase Prior to Month 12
timeFrame: Prior to month 12
measure: Duration of Active Treatment Phase up to Month 24
timeFrame: up to month 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Chongqing City
country: China
facility: Novartis Investigative Site
state: Chongqing
city: Lanzhou
country: China
facility: Novartis Investigative Site
state: Gansu
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 City
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanchang
country: China
facility: Novartis Investigative Site
state: Jiangxi
city: Shenyang
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Qingdao
country: China
facility: Novartis Investigative Site
state: Shandong
city: Taiyuan
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: 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: Chongqing
country: China
facility: Novartis Investigative Site
city: Shanghai
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: