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Ranibizumab Treatment for Retinal Vein Occlusion

Primary Purpose

Macular Edema Due to BRVO/CRVO

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Ranibizumab, 0.5mg, Intravitreal
Sponsored by
Kyoto University, Graduate School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema Due to BRVO/CRVO

Eligibility Criteria

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

Inclusion Criteria:

  • Signed informed consent form
  • Male or female of aged 18 years or older
  • Macula edema secondary to BRVO/CRVO
  • Decrease of VA due to macular edema

Exclusion Criteria:

  • Prior episode of RVO
  • Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
  • Ocular disorders in the study eye that may confound interpretation of study results
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
  • The pregnant or lactating woman

Sites / Locations

  • Department of Ophthalmology, Kyoto University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intravitreal Lucentis 0.5mg

Arm Description

One arm

Outcomes

Primary Outcome Measures

Mean foveal thickness measured by SD-OCT

Secondary Outcome Measures

Full Information

First Posted
October 20, 2013
Last Updated
March 8, 2017
Sponsor
Kyoto University, Graduate School of Medicine
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01968616
Brief Title
Ranibizumab Treatment for Retinal Vein Occlusion
Official Title
Predictive Factors of 2-year Visual Outcome in Retinal Vein Occlusion Following Intravitreal Ranibizumab Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University, Graduate School of Medicine
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by SD-OCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Due to BRVO/CRVO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal Lucentis 0.5mg
Arm Type
Other
Arm Description
One arm
Intervention Type
Drug
Intervention Name(s)
Ranibizumab, 0.5mg, Intravitreal
Primary Outcome Measure Information:
Title
Mean foveal thickness measured by SD-OCT
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form Male or female of aged 18 years or older Macula edema secondary to BRVO/CRVO Decrease of VA due to macular edema Exclusion Criteria: Prior episode of RVO Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye) Ocular disorders in the study eye that may confound interpretation of study results History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO The pregnant or lactating woman
Facility Information:
Facility Name
Department of Ophthalmology, Kyoto University Hospital
City
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nagahisa Yoshimura, MD, PhD
Phone
+81-75-751-3248
Email
nagaeye@kuhp.kyoto-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Akitaka Tsujikawa, MD. PhD
Phone
+81-75-751-3250
Email
tujikawa@kuhp.kyoto-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Nagahisa Yoshimura, M.D, PhD

12. IPD Sharing Statement

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Ranibizumab Treatment for Retinal Vein Occlusion

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