Clinical trial NCT01976338: Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)
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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema Secondary to Branch Retinal Vein Occlusion
Keywords: BRVO
macular edema
vision impairment
retinal vein occlusion
ranibizumab
branch retinal vein occlusion
anti-VEGF therapy
RFB002
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-05
Enrollment: 283
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: Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO


Eligibility criteria: 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 unless 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
* 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
* Panretinal or focal/drid laser photocoagulation within the last few months

Primary outcomes:
measure: Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6
timeFrame: Baseline to Month 1 through Month 6
Secondary outcomes:
measure: Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12
timeFrame: Baseline to Month 1 through Month 12
measure: Best Corrected Visual Acuity (BCVA) Change Over Time
timeFrame: Month 1 through Month 12
measure: Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
timeFrame: Baseline to month 12
measure: Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye
timeFrame: Baseline to 12 months
measure: Change in Central-Sub-Field- Thickness (CSFT) Over Time
timeFrame: Month 1 to month 12
measure: Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time
timeFrame: month 3, 6 and 12
measure: Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time
timeFrame: Months 3, 6 and 12
measure: Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time
timeFrame: Months 3, 6 and 12
measure: Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12
timeFrame: Baseline, months 3, 6 and 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: Chongqing
country: China
facility: Novartis Investigative Site
state: Chongqing
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: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Nantong
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: 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: 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: Hongkong
country: Hong Kong
facility: Novartis Investigative Site
city: Bandung
country: Indonesia
facility: Novartis Investigative Site
state: Jawa Barat
city: Jakarta
country: Indonesia
facility: Novartis Investigative Site
city: Manila
country: Philippines
facility: Novartis Investigative Site
state: Metro Manila
city: San Juan City
country: Philippines
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Lin-Kou
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Hanoi
country: Vietnam
facility: Novartis Investigative Site
city: Ho Chi Minh City
country: Vietnam
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Wei W, Weisberger A, Zhu L, Cheng Y, Liu C; BLOSSOM Study Group. Efficacy and Safety of Ranibizumab in Asian Patients with Branch Retinal Vein Occlusion: Results from the Randomized BLOSSOM Study. Ophthalmol Retina. 2020 Jan;4(1):57-66. doi: 10.1016/j.oret.2019.08.001. Epub 2019 Aug 13.