Ranibizumab Treatment for Retinal Vein Occlusion

Not Applicable

• Conditions: Macular Edema Due to BRVO/CRVO
• Interventions: Drug: Ranibizumab, 0.5mg, Intravitreal

• Registration Number: NCT01968616
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-20
• Study First Submitted QC: 2013-10-20
• Study First Posted: 2013-10-24
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-10
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravitreal Lucentis 0.5mg	Ranibizumab, 0.5mg, Intravitreal	One arm

Primary Outcome Measures

Name	Time	Method
Mean foveal thickness measured by SD-OCT	2 years

Trial Locations

Locations (1)

Department of Ophthalmology, Kyoto University Hospital; 🇯🇵 Kyoto, Japan