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Trial record 80 of 81 for:    CRVO - Central Retinal Vein Occlusion

Ranibizumab Treatment for Retinal Vein Occlusion

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ClinicalTrials.gov Identifier: NCT01968616
Recruitment Status : Recruiting
First Posted : October 24, 2013
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Nagahisa Yoshimura, Kyoto University, Graduate School of Medicine

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.

Condition or disease Intervention/treatment Phase
Macular Edema Due to BRVO/CRVO Drug: Ranibizumab, 0.5mg, Intravitreal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predictive Factors of 2-year Visual Outcome in Retinal Vein Occlusion Following Intravitreal Ranibizumab Treatment
Study Start Date : September 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Intravitreal Lucentis 0.5mg
One arm
Drug: Ranibizumab, 0.5mg, Intravitreal



Primary Outcome Measures :
  1. Mean foveal thickness measured by SD-OCT [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968616


Locations
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Japan
Department of Ophthalmology, Kyoto University Hospital Recruiting
Kyoto, Japan
Contact: Nagahisa Yoshimura, MD, PhD    +81-75-751-3248    nagaeye@kuhp.kyoto-u.ac.jp   
Contact: Akitaka Tsujikawa, MD. PhD    +81-75-751-3250    tujikawa@kuhp.kyoto-u.ac.jp   
Principal Investigator: Nagahisa Yoshimura, M.D, PhD         
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Novartis

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Responsible Party: Nagahisa Yoshimura, Department of Ophthalmology & Visual Sciences, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01968616     History of Changes
Other Study ID Numbers: KY-RV-R
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Venous Thrombosis
Macular Edema
Macular Degeneration
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents