NCT01968616

Brief Summary

In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by SD-OCT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

6 years

First QC Date

October 20, 2013

Last Update Submit

March 8, 2017

Conditions

Macular Edema Due to BRVO/CRVO

Outcome Measures

Primary Outcomes (1)

  • Mean foveal thickness measured by SD-OCT

    2 years

Study Arms (1)

Intravitreal Lucentis 0.5mg

OTHER

One arm

Drug: Ranibizumab, 0.5mg, Intravitreal

Interventions

Ranibizumab, 0.5mg, IntravitrealDRUG
Intravitreal Lucentis 0.5mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent form
  • Male or female of aged 18 years or older
  • Macula edema secondary to BRVO/CRVO
  • Decrease of VA due to macular edema

You may not qualify if:

  • Prior episode of RVO
  • Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye)
  • Ocular disorders in the study eye that may confound interpretation of study results
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO
  • The pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Kyoto University Hospital

Kyoto, Kyoto, Japan

RECRUITING

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Ophthalmology & Visual Sciences

Study Record Dates

First Submitted

October 20, 2013

First Posted

October 24, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

JP(1)