Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)

Branch Retinal Vein Occlusion Clinical Trial

— Blossom  

Official title:

A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Branch Retinal Vein Occlusion (BRVO) [Blossom]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976338
• Other study ID #: CRFB002E2303
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2013
• Last updated: February 14, 2017
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 and 73 letters in one eye and at least 35 letters in the other eye.

Exclusion Criteria:

• Pregnant or nursing women or women of child bearing potential without using an effective contraception

• Stroke or myocard infarction within 3 months prior to study

• History of malignancy within the past 5 years

• Uncontrolled hypertension

• Active infection or inflammation in any eye

• monocular patients

• use of corticosteroids for at least 30 days in the last 6 months

• treatment with anti-angiogenic drugs in any eye within last 3 months

• laser photocoagulation within the last few months

• Other protocol defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab 0.5 mg
intravitreal injection of 0.05 ml

Other:
• Sham injection
Sham intravitreal injection

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changsha	Hunan
China	Novartis Investigative Site	Chengdu	Sichuan
China	Novartis Investigative Site	Chongqing	Chongqing
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Harbin	Heilongjiang
China	Novartis Investigative Site	Nanchang	Jiangxi
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nanjing	Jiangsu
China	Novartis Investigative Site	Nantong	Jiangsu
China	Novartis Investigative Site	Qingdao	Shandong
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shantou	Guangdong
China	Novartis Investigative Site	Tianjin	Tianjin
China	Novartis Investigative Site	Tianjin	Tianjin
China	Novartis Investigative Site	Wenzhou	Zhejiang
China	Novartis Investigative Site	Wuhan	Hubei
Hong Kong	Novartis Investigative Site	Hongkong
Indonesia	Novartis Investigative Site	Bandung	Jawa Barat
Indonesia	Novartis Investigative Site	Jakarta
Philippines	Novartis Investigative Site	Manila	Metro Manila
Philippines	Novartis Investigative Site	San Juan City
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Lin-Kou
Taiwan	Novartis Investigative Site	Taipei
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

China,  Hong Kong,  Indonesia,  Philippines,  Taiwan,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Best Corrected Visual Acuity (BCVA) in patients treated with ranibizumab 0.5 mg prn or sham injection.	Assessment of efficacy of treatment with 0.5 mg ranibizumab prn compared to treatment with sham injection over 6 months. The change of BCVA will be assessed by the change from baseline BCVA to the average level of BCVA over all monthly assessments from month 1 to month 6	Baseline, 6 months
Secondary	Average change of Best Corrected Visual Acuity (BCVA) in patients treated with ranibizumab 0.5 mg prn	The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet.	Baseline, 12 months
Secondary	Best Corrected Visual Acuity (BCVA) change over time	The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet.	12 months
Secondary	Change in Central-Sub-Field- Thickness (CSFT)	Retinal thickness was assessed by Optical Coherence Tomography (OCT) and was analyzed by the central reading center.	Baseline, 12 months
Secondary	Categorical BCVA improvement over time	BCVA improvement of >= 5, >= 10, >=15 and >= 30 letters from baseline over time (month 1 through month 12)	12 months
Secondary	Percentage of patients with Best Corrected Visual Acuity (BCVA) loss < 15 letter	BCVA loss < 15 letters from baseline over time (month 1 through month 12)	12 months
Secondary	Number of patients with active leakage	Area of leakage was assessed by fluorescein angiography in conjunction with color fundus photography. Analysis was performed by the central reading center.	month 3, 6 and 12
Secondary	The change in patient reported outcomes in NEI-VFQ-25 score (composite score and subscales) at month 3, 6 and 12 compared to baseline	Effect of treatment on absolute composite- and subscale scores and changes from baseline over time of vision related quality of life assessed by the patient on the Vision Functioning Questionaire (VFQ-25)	Baseline, months 3, 6 and 12
Secondary	Number of participants with Adverse events as a measure of Safety and Tolerability		12 months
Secondary	Number of re-treatments and re-treatment patterns	Number of re-treatments and re-treatment patterns (eg: duration of treatment-free intervals; duration of active treatment phase)	12 months