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

NCT01976338 | Completed Phase 3 Results

• 1 other identifier: CRFB002E2303
• Study Type: interventional
• Target: 283
• Locations: 6 countries
• Sites: 33

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

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

Outcome Measures

Primary Outcomes (1)

• Average Change in Best Corrected Visual Acuity (BCVA) From 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 Outcomes (9)

• Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12

  Baseline to Month 1 through Month 12

• Best Corrected Visual Acuity (BCVA) Change Over Time

  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

  Baseline to month 12

• Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye

  Baseline to 12 months

• Change in Central-Sub-Field- Thickness (CSFT) Over Time

  Month 1 to month 12

Study Arms (2)

Ranibizumab 0.5 mg

EXPERIMENTAL

PRN Intravitreal injection

Drug: Ranibizumab 0.5 mg

Sham injection

SHAM COMPARATOR

As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Other: Sham injection

Interventions

Ranibizumab 0.5 mg DRUG

intravitreal injection of 0.05 ml

Ranibizumab 0.5 mg

Sham injection OTHER

Sham intravitreal injection

Also known as: Sham

Sham injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (33)

Novartis Investigative Site

Beijing, Beijing Municipality, 100191, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

Location

Novartis Investigative Site

Chongqing, Chongqing Municipality, 400042, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510060, China

Location

Novartis Investigative Site

Shantou, Guangdong, 515041, China

Location

Novartis Investigative Site

Harbin, Heilongjiang, 150001, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430070, China

Location

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210006, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

Location

Novartis Investigative Site

Nantong, Jiangsu, 226000, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Qingdao, Shandong, 266011, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300020, China

Location

Novartis Investigative Site

Tianjin, Tianjin Municipality, 300070, China

Location

Novartis Investigative Site

Wenzhou, Zhejiang, 325027, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Beijing, 100176, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Chongqing, 400038, China

Location

Novartis Investigative Site

Shanghai, 200080, China

Location

Novartis Investigative Site

Shanghai, 200092, China

Location

Novartis Investigative Site

Hong Kong, Hong Kong, Hong Kong

Location

Novartis Investigative Site

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

Novartis Investigative Site

Bandung, West Java, 40117, Indonesia

Location

Novartis Investigative Site

Manila, National Capital Region, 1000, Philippines

Location

Novartis Investigative Site

San Juan City, Philippines, 1500, Philippines

Location

Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

Location

Novartis Investigative Site

Linkou District, 33305, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan

Location

Novartis Investigative Site

Hanoi, Vietnam, 10000, Vietnam

Location

Novartis Investigative Site

Ho Chi Minh City, Vietnam, 70000, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 31902472 DERIVED

MeSH Terms

Conditions

Macular Edema; Vision Disorders; Retinal Vein Occlusion

Interventions

Ranibizumab; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

One patient was randomized to the ranibizumab group but received no study treatment during the study period and discontinued the study after Visit 2. Therefore, excluded from the Safety set

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 5, 2013
• Study Start: November 12, 2013
• Primary Completion: March 28, 2016
• Study Completion: March 28, 2016
• Last Updated: May 8, 2017
• Results First Posted: May 8, 2017

Record last verified: 2017-03

Locations

VN (2); TW (3); CN (23); ID (2); HK (1); PH (2)