Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion
RVO in Japan
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)
1 other identifier
interventional
47
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2011
Shorter than P25 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 20, 2011
CompletedFirst Posted
Study publicly available on registry
June 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedNovember 18, 2016
November 1, 2016
10 months
June 20, 2011
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 months
Secondary Outcomes (5)
Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit
3 months
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
3 months
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
3 months
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
3 months
Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events
3 months
Study Arms (1)
ranibizumab intravitreal injection
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8560, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582, Japan
Novartis Investigative Site
Kita-gun, Kagawa-ken, 761-0793, Japan
Novartis Investigative Site
Kyoto, Kyoto, 606-8507, Japan
Novartis Investigative Site
Osaka, Osaka, 545-8586, Japan
Novartis Investigative Site
Suita, Osaka, 565-0871, Japan
Novartis Investigative Site
Ohtsu, Shiga, 520-2192, Japan
Related Publications (1)
Kamei M, Terasaki H, Yoshimura N, Shiraga F, Ogura Y, Grotzfeld AS, Pilz S, Ishibashi T. Short-term efficacy and safety of ranibizumab for macular oedema secondary to retinal vein occlusion in Japanese patients. Acta Ophthalmol. 2017 Feb;95(1):e29-e35. doi: 10.1111/aos.13196. Epub 2016 Sep 22.
PMID: 27654837RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY DIRECTOR
Novartis Pharma AG
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2011
First Posted
June 21, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
November 18, 2016
Record last verified: 2016-11