Ranibizumab Treatment for Retinal Vein Occlusion | NCT01968616

Studies
Ranibizumab Treatment for Retinal Vein Occlusion

NCT01968616

Sponsor

Kyoto University, Graduate School of Medicine

Status

Unknown status

Last Update Posted

Mar 10, 2017Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Macular Edema Due to BRVO/CRVO

Interventions

Ranibizumab, 0.5mg, Intravitreal

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Oct 20, 2013

First Submission Date that Met QC Criteria

Oct 20, 2013

First Posted Date

Oct 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2017

Last Update Posted Date

Mar 10, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nagahisa Yoshimura, Department of Ophthalmology & Visual Sciences, Kyoto University, Graduate School of MedicinePrincipal Investigator

Lead Sponsor

Kyoto University, Graduate School of MedicineOTHER

Collaborators

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravitreal Lucentis 0.5mg	Other	One arm	Drug: Ranibizumab, 0.5mg, Intravitreal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab, 0.5mg, Intravitreal	Drug		Intravitreal Lucentis 0.5mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean foveal thickness measured by SD-OCT		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, Kyoto University Hospital	Recruiting	Kyoto	Kyoto		Japan

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided