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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01377597
First received: June 20, 2011
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Retinal Vein Occlusion
 Drug: ranibizumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ranibizumab intravitreal injection Drug: ranibizumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377597

Locations
Japan
Novartis Investigative Site
Nagoya, Aichi, Japan, 467-8602
Novartis Investigative Site
Nagoya, Aichi, Japan, 466-8560
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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01377597     History of Changes
Other Study ID Numbers: CRFB002E2301
Study First Received: June 20, 2011
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Vision, Low
Vision Disorders
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
 Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013