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Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion (RVO in Japan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01377597
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Drug: ranibizumab Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : June 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ranibizumab intravitreal injection Drug: ranibizumab


Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377597


Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 466-8560
Novartis Investigative Site
Nagoya, Aichi, Japan, 467-8602
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site
Kita-gun, Kagawa, Japan, 761-0793
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site
Ohtsu, Shiga, Japan, 520-2192
Novartis Investigative Site
Kyoto, Japan, 606-8507
Novartis Investigative Site
Osaka, Japan, 545-8586
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharma AG Novartis Pharmaceuticals
More Information

Additional Information:
Publications:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01377597     History of Changes
Other Study ID Numbers: CRFB002E2301
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
retinal vein occlusion
branch retinal vein occlusion
central retinal vein occlusion
visual impairment
macular edema
ranibizumab

Additional relevant MeSH terms:
Retinal Vein Occlusion
Vision Disorders
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents