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Status unknownNCT02091505CRVOUpdated Mar 19, 2014

Predictive Factors of Ranibizumab Treatment in Macular Edema With CRVO

An interventional study of Ranibizumab in Central Retinal Vein Occlusion, sponsored by Mie University. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-03-19.

Sponsored by Mie University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Central Retinal Vein Occlusion
03

In context

Retinal Vein Occlusion

291 studies on the registry are indexed under Retinal Vein Occlusion; 29 are open to participants now.

This study's planned enrollment of 30 is below the median of 49 across 217 interventional studies indexed under Retinal Vein Occlusion.

Browse Retinal Vein Occlusion studies →

Lead sponsor

Mie University is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any past history of treatment for macular edema (e.g. anti-VEGF injection, steroid, vitrectomy)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intravitreal injection of Ranibizumab

    Drug: Ranibizumab

Interventions

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What researchers measure

Primary outcomes

  1. Best-corrected visual acuity

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Mie University Hospital
    Tsu, Aichi-ken 514-8507, Japan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 20381871 ↗
  • 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. PubMed 23415775 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013 and a primary completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2014
First posted
Mar 19, 2014
Start
Dec 2013
Primary completionEst.
May 2016
Last update
Mar 19, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02091505
Lead sponsor
Mie University
Responsible party
Mineo Kondo (MD. PhD., Mie University) — Principal investigator
First posted
Mar 19, 2014
Start date
Dec 2013
Primary completion
May 2016 (estimated)
Last update
Mar 19, 2014

Study contacts

Mineo Kondo, MD, PhD
Contact
mineo@clin.medic.mie-u.ac.jp
+81-59-231-5027
Mineo Kondo, MD, PhD
study director · Mie University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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