Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

Not Applicable

• Conditions: Central Retinal Vein Occlusion
• Interventions: Drug: Ranibizumab

• Registration Number: NCT02091505
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-16
• Study First Submitted QC: 2014-03-17
• Last Update Submitted: 2014-03-17
• Study First Posted: 2014-03-19
• Last Update Posted: 2014-03-19
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravitreal injection of Ranibizumab	Ranibizumab	-

Primary Outcome Measures

Name	Time	Method
Best-corrected visual acuity	12 months

Trial Locations

Locations (1)

Mie University Hospital; 🇯🇵 Tsu, Aichi, Japan