Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

Central Retinal Vein Occlusion Clinical Trial

— CRVO  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02091505
• Other study ID #: MKONDO-CRVO
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2014
• Last updated: March 17, 2014
• Start date: December 2013

Study information

• Verified date: March 2014
• Source: Mie University
• Contact: Mineo Kondo, MD, PhD
• Phone: +81-59-231-5027
• Email: mineo[@]clin.medic.mie-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab

Locations

Country	Name	City	State
Japan	Mie University Hospital	Tsu	Aichi

Sponsors (1)

Lead Sponsor	Collaborator
Mie University

Country where clinical trial is conducted

Japan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity		12 months	No

External Links

•   Department of Ophthalmology, Mie University Graduate School of Medicine