Ranibizumab Treatment for Retinal Vein Occlusion

March 8, 2017 updated by: Nagahisa Yoshimura, Kyoto University, Graduate School of Medicine

Predictive Factors of 2-year Visual Outcome in Retinal Vein Occlusion Following Intravitreal Ranibizumab Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan
        • Recruiting
        • Department of Ophthalmology, Kyoto University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nagahisa Yoshimura, M.D, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intravitreal Lucentis 0.5mg
One arm
Drug: Ranibizumab, 0.5mg, Intravitreal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean foveal thickness measured by SD-OCT
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Collaborators

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

October 20, 2013

First Submitted That Met QC Criteria

October 20, 2013

First Posted (Estimate)

October 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-RV-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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