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

March 27, 2017 updated by: Novartis Pharmaceuticals

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]

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

283

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Novartis Investigative Site
      • Beijing, China, 100034
        • Novartis Investigative Site
      • Beijing, China, 100176
        • Novartis Investigative Site
      • Chongqing, China, 400038
        • Novartis Investigative Site
      • Shanghai, China, 200080
        • Novartis Investigative Site
      • Shanghai, China, 200092
        • Novartis Investigative Site
    • Beijing
      • Beijing, Beijing, China, 100730
        • Novartis Investigative Site
      • Beijing, Beijing, China, 100191
        • Novartis Investigative Site
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Novartis Investigative Site
      • Shantou, Guangdong, China, 515041
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430070
        • Novartis Investigative Site
    • Hunan
      • Changsha, Hunan, China, 410011
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 210006
        • Novartis Investigative Site
      • Nantong, Jiangsu, China, 226000
        • Novartis Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Novartis Investigative Site
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Novartis Investigative Site
      • Tianjin, Tianjin, China, 300070
        • Novartis Investigative Site
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Novartis Investigative Site
  • Hong Kong
      • Hongkong, Hong Kong
        • Novartis Investigative Site
  • Indonesia
      • Jakarta, Indonesia, 10430
        • Novartis Investigative Site
    • Jawa Barat
      • Bandung, Jawa Barat, Indonesia, 40117
        • Novartis Investigative Site
  • Philippines
      • San Juan City, Philippines, 1500
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Philippines, 1000
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Novartis Investigative Site
      • Lin-Kou, Taiwan, 33305
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
  • Vietnam
      • Hanoi, Vietnam, 10000
        • Novartis Investigative Site
      • Ho Chi Minh City, Vietnam, 70000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab 0.5 mg
PRN Intravitreal injection
Drug: Ranibizumab 0.5 mg
intravitreal injection of 0.05 ml
Sham Comparator: Sham injection
As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
Other: Sham injection
Sham intravitreal injection
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6
Time Frame: Baseline to Month 1 through Month 6
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.
Baseline to Month 1 through Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12
Time Frame: Baseline to Month 1 through Month 12
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
Baseline to Month 1 through Month 12
Best Corrected Visual Acuity (BCVA) Change Over Time
Time Frame: Month 1 through Month 12
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
Month 1 through Month 12
Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
Time Frame: Baseline to month 12
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters
Baseline to month 12
Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye
Time Frame: Baseline to 12 months
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
Baseline to 12 months
Change in Central-Sub-Field- Thickness (CSFT) Over Time
Time Frame: Month 1 to month 12
OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center
Month 1 to month 12
Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time
Time Frame: month 3, 6 and 12
Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes
month 3, 6 and 12
Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time
Time Frame: Months 3, 6 and 12
Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes
Months 3, 6 and 12
Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time
Time Frame: Months 3, 6 and 12
Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes
Months 3, 6 and 12
Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12
Time Frame: Baseline, months 3, 6 and 12
The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.
Baseline, months 3, 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2013

Primary Completion (Actual)

March 28, 2016

Study Completion (Actual)

March 28, 2016

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 29, 2013

First Posted (Estimate)

November 5, 2013

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002E2303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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