Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

NCT ID: NCT02091505

Last Updated: 2014-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Central Retinal Vein Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravitreal injection of Ranibizumab

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

Interventions

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Ranibizumab

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mie University

OTHER

Sponsor Role lead

Responsible Party

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Mineo Kondo

MD. PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mineo Kondo, MD, PhD

Role: STUDY_DIRECTOR

Mie University Hospital

Locations

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Mie University Hospital

Tsu, Aichi-ken, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Mineo Kondo, MD, PhD

Role: CONTACT

+81-59-231-5027

Facility Contacts

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Mineo Kondo, MD. PhD.

Role: primary

+81-59-231-5027

References

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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.

Reference Type BACKGROUND
PMID: 20381871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23415775 (View on PubMed)

Related Links

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http://www.medic.mie-u.ac.jp/ophthalmology/

Department of Ophthalmology, Mie University Graduate School of Medicine

Other Identifiers

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MKONDO-CRVO

Identifier Type: -

Identifier Source: org_study_id

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