Clinical trial NCT02091505: Predictive Factors of Ranibizumab Treatment in Macular Edema With 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Retinal Vein Occlusion
Lead sponsor: Mie University
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tsu
country: Japan
facility: Mie University Hospital
state: Aichi
Study officials:
affiliation: Mie University Hospital
name: Mineo Kondo, MD, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.