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

Primary Purpose

Retinal Vein Occlusion

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring retinal vein occlusion, branch retinal vein occlusion, central retinal vein occlusion, visual impairment, macular edema, ranibizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ranibizumab intravitreal injection

Arm Description

Outcomes

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

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
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
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
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
Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events

Full Information

First Posted
June 20, 2011
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01377597
Brief Title
Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion
Acronym
RVO in Japan
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 Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion
Keywords
retinal vein occlusion, branch retinal vein occlusion, central retinal vein occlusion, visual impairment, macular edema, ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ranibizumab intravitreal injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis Pharma AG
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Novartis Investigative Site
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Novartis Investigative Site
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Novartis Investigative Site
City
Suita-city
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Novartis Investigative Site
City
Ohtsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27654837
Citation
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.
Results Reference
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Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion

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