Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)

NCT01976312 | Completed Phase 3 Results

• 1 other identifier: CRFB002E2302
• Study Type: interventional
• Target: 252
• Locations: 7 countries
• Sites: 34

Brief Summary

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

Conditions

Central Retinal Vein Occlusion

Keywords

CRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab

Outcome Measures

Primary Outcomes (1)

• Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3

  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 3 and compared to Baseline.

  Baseline, 3 Months

Secondary Outcomes (6)

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

  Baseline, 12 months

• Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time

  Month 1 to 12 months

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

  Month 1 to month 12

• Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time

  Month 1 to month 12

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

  Month 1 to 12 months

Study Arms (2)

Ranibizumab 0.5 mg

EXPERIMENTAL

PRN intravitreal injection

Drug: Ranibizumab 0.5 mg

Sham injection

SHAM COMPARATOR

As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections

Other: Sham injection

Interventions

Sham injection OTHER

Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.

Sham injection

Ranibizumab 0.5 mg DRUG

Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only

Also known as: Lucentis

Ranibizumab 0.5 mg

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 central retinal vein occlusion (CRVO) with a BCVA between 24 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 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 3 and 4 months respectively

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (34)

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

Ahmedabad, Gujarat, 380 016, India

Location

Novartis Investigative Site

Bhubaneswar, Odisha, 751 024, India

Location

Novartis Investigative Site

Bandung, West Java, 40117, Indonesia

Location

Novartis Investigative Site

Jakarta, 10430, 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

Linkou District, 33305, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan

Location

Novartis Investigative Site

Hanoi, 10000, Vietnam

Location

Novartis Investigative Site

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema; Vision Disorders

Interventions

salicylhydroxamic acid; Ranibizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

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 14, 2016
• Study Completion: March 14, 2016
• Last Updated: May 30, 2017
• Results First Posted: April 24, 2017

Record last verified: 2017-04

Locations

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