Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

Mie University

Status: Unknown

Conditions: Central Retinal Vein Occlusion

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02091505

MKONDO-CRVO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intravitreal injection of Ranibizumab

Experimental group

Treatment:

Drug: Ranibizumab