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Trial record 11 of 81 for:    CRVO - Central Retinal Vein Occlusion

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

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ClinicalTrials.gov Identifier: NCT02091505
Recruitment Status : Unknown
Verified March 2014 by Mineo Kondo, Mie University.
Recruitment status was:  Recruiting
First Posted : March 19, 2014
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Mineo Kondo, Mie University

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.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Drug: Ranibizumab Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Intravitreal injection of Ranibizumab Drug: Ranibizumab



Primary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT02091505


Contacts
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Contact: Mineo Kondo, MD, PhD +81-59-231-5027 mineo@clin.medic.mie-u.ac.jp

Locations
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Japan
Mie University Hospital Recruiting
Tsu, Aichi, Japan, 514-8507
Contact: Mineo Kondo, MD. PhD.    +81-59-231-5027    mineo@clin.medic.mie-u.ac.jp   
Sponsors and Collaborators
Mie University
Investigators
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Study Director: Mineo Kondo, MD, PhD Mie University Hospital

Additional Information:
Publications:
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Responsible Party: Mineo Kondo, MD. PhD., Mie University
ClinicalTrials.gov Identifier: NCT02091505     History of Changes
Other Study ID Numbers: MKONDO-CRVO
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014

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