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Status unknownNCT02527733Updated Aug 19, 2015

Retinal Sensitivity in BRVO After Anti-VEGF Therapy

A Phase 4 interventional study of Ranibizumab and Ranibizumab and laser in Branch Retinal Vein Occlusion, sponsored by Fukushima Medical University. Status unknown at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-19.

Sponsored by Fukushima Medical University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.

02

Conditions studied

  • Branch 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 50 is close to the median of 49 across 217 interventional studies indexed under Retinal Vein Occlusion.

Browse Retinal Vein Occlusion studies →

Lead sponsor

Fukushima Medical University is the lead sponsor of 10 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
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

  • Treatment naive patients of branch retinal vein occlusion with visual acuity of less than 1.0 and macular edema of more than 250 micrometers in foveal thickness.

Exclusion criteria

Exclusion Criteria:

  • Patients with history of treatment for branch retinal vein occlusion, possibility of pregnancy, allergy for ranibizumab, intraocular infection, or severe inflammation will be excluded.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Ranibizumab

    After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.

    Drug: Ranibizumab

  • Active comparator
    Ranibizumab and laser

    After initial single intravitreal injection of ranibizumab (0.5mg), participants receive monthly as-needed injection of ranibizumab (0.5mg) when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers. Macular laser photocoagulation will be performed when visual acuity is less than 1.0 and foveal thickness is more than 250 micrometers.

    Drug: Ranibizumab and laser

Interventions

06

What researchers measure

Primary outcomes

  1. Retinal sensitivity measured by microperimetry (MP-3, NIDEK, Japan)

    Time frame: At 12 months

07

Study locations

1 of 1 sites recruiting
  • Department of Ophthalmology, Fukushima Medical University
    Fukushima, Fukushima 9601295, Japan
    • Akira Ojima, M.D., Ph.D · Contact · ao@fmu.ac.jp · +81-24-548-2111
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02527733
Lead sponsor
Fukushima Medical University
Responsible party
Akira Ojima (Assistant Professor, Fukushima Medical University) — Principal investigator
First posted
Aug 19, 2015
Start date
Jun 2015
Primary completion
Sep 2017 (estimated)
Last update
Aug 19, 2015

Study contacts

Akira Ojima, M.D., Ph.D
Contact
ao@fmu.ac.jp
+81-24-548-2111
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Ranibizumab · Cycloxydim

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