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Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO (CRVO)

Primary Purpose

Central Retinal Vein Occlusion

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Mie University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Macular edema associated with central retinal vein occlusion
  • Best corrected visual acuity < 20/30
  • Central macular thickness > 300
  • Period from symptom onset to treatment < 12 months

Exclusion Criteria:

  • Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)

Sites / Locations

  • Mie University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravitreal injection of Ranibizumab

Arm Description

Outcomes

Primary Outcome Measures

Best-corrected visual acuity

Secondary Outcome Measures

Full Information

First Posted
March 16, 2014
Last Updated
March 17, 2014
Sponsor
Mie University
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1. Study Identification

Unique Protocol Identification Number
NCT02091505
Brief Title
Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO
Acronym
CRVO
Official Title
Predictive Factors of Treatment Outcome After Intravitreal Injection of Lucentis (Ranibizumab) in Eyes With Macular Edema Associated With Central Retinal Vein Occlusion (CRVO)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mie University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Recent studies have shown that intravitreal injection of anti-VEGF agent, Lucentis (Ranibizumab) is effective for macular edema associated with central retinal vein occlusion (CRVO). However, there is little information on whether there are any predictive factors of treatment outcome after this treatment. We plan to perform comprehensive functional and imaging tests to determine significant predictive factors.
Detailed Description
The purpose of the present study is to investigate predictive factors of treatment outcome after intravitreal injection of Lucentis (Ranibizumab) in eyes with macular edema associated with central retinal vein occlusion (CRVO) using various comprehensive clinical tests including visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, new flicker electroretinogram (ERG) using skin electrodes. Corrected visual acuity, visual filed, spectral-domain optical coherence tomography (SD-OCT), ultra wide-field fluorescein angiography, and new flicker electroretinogram (ERG) using skin electrodes are performed before and 3, 6, 9, 12 months after the treatment. Predictive factors of treatment outcome are statistically analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intravitreal injection of Ranibizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Primary Outcome Measure Information:
Title
Best-corrected visual acuity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Macular edema associated with central retinal vein occlusion Best corrected visual acuity < 20/30 Central macular thickness > 300 Period from symptom onset to treatment < 12 months Exclusion Criteria: Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mineo Kondo, MD, PhD
Phone
+81-59-231-5027
Email
mineo@clin.medic.mie-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mineo Kondo, MD, PhD
Organizational Affiliation
Mie University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Mie University Hospital
City
Tsu
State/Province
Aichi
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mineo Kondo, MD. PhD.
Phone
+81-59-231-5027
Email
mineo@clin.medic.mie-u.ac.jp

12. IPD Sharing Statement

Citations:
PubMed Identifier
20381871
Citation
Brown DM, Campochiaro PA, Singh RP, Li Z, Gray S, Saroj N, Rundle AC, Rubio RG, Murahashi WY; CRUISE Investigators. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1124-1133.e1. doi: 10.1016/j.ophtha.2010.02.022. Epub 2010 Apr 9.
Results Reference
background
PubMed Identifier
23415775
Citation
Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.
Results Reference
background
Links:
URL
http://www.medic.mie-u.ac.jp/ophthalmology/
Description
Department of Ophthalmology, Mie University Graduate School of Medicine

Learn more about this trial

Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

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