- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377597
Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion (RVO in Japan)
November 16, 2016 updated by: Novartis Pharmaceuticals
A 3-month, Phase III, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of 0.5 mg Ranibizumab Monthly Intravitreal Injections as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Branch or Central Retinal Vein Occlusion (RVO)
The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.
Study Overview
Study Type
Interventional
Enrollment (Actual)
47
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
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Kyoto, Japan, 606-8507
- Novartis Investigative Site
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Osaka, Japan, 545-8586
- Novartis Investigative Site
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Aichi
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Nagoya, Aichi, Japan, 466-8560
- Novartis Investigative Site
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Nagoya, Aichi, Japan, 467-8602
- Novartis Investigative Site
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Fukuoka
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Fukuoka-city, Fukuoka, Japan, 812-8582
- Novartis Investigative Site
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Kagawa
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Kita-gun, Kagawa, Japan, 761-0793
- Novartis Investigative Site
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Osaka
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Suita-city, Osaka, Japan, 565-0871
- Novartis Investigative Site
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Shiga
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Ohtsu, Shiga, Japan, 520-2192
- Novartis Investigative Site
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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:
- Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1
- Best-corrected visual acuity (BCVA):
- CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2
- BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2
Exclusion Criteria:
- Pregnant or nursing women
- History of stroke
- Uncontrolled blood pressure
- Active ocular infection or intraocular inflammation in either eye
- Uncontrolled glaucoma in either eye
- Neovascularization of the iris or neovascular glaucoma in either eye
- Prior episode of RVO more than 12 months prior to Visit 1 in the study eye
- Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2
- Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye
- Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye
- Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye
- Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye
- Use of any intra-ocular corticosteroid implants in the study eye
Other protocol-defined inclusion/exclusion criteria may apply
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ranibizumab intravitreal injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit
Time Frame: 3 months
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3 months
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Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3
Time Frame: 3 months
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3 months
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Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3
Time Frame: 3 months
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3 months
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Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3
Time Frame: 3 months
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3 months
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Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events
Time Frame: 3 months
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
June 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
June 20, 2011
First Submitted That Met QC Criteria
June 20, 2011
First Posted (Estimate)
June 21, 2011
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Retinal Diseases
- Embolism and Thrombosis
- Venous Thrombosis
- Thrombosis
- Retinal Vein Occlusion
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Ranibizumab
Other Study ID Numbers
- CRFB002E2301
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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