Combination Treatment of Intravitreal Ranibizumab, Focal/... | NCT02131350

Studies
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema

NCT02131350

Sponsor

Shinshu University

Status

Completed

Last Update Posted

Sep 7, 2018Actual

Enrollment

40Actual

Phase

Phase 4

Conditions

Diabetic Macula Edema

Interventions

Photocoagulation
Ranibizumab

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014Actual

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2018Actual

First Submitted Date

Apr 22, 2014

First Submission Date that Met QC Criteria

May 2, 2014

First Posted Date

May 6, 2014Estimated

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

Sep 5, 2018

Last Update Posted Date

Sep 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Takao Hirano, Department of Ophthalmology Shinshu University School of Medicine, Shinshu UniversityPrincipal Investigator

Lead Sponsor

Shinshu UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ranibizumab with Photocoagulation	Experimental		Procedure: Photocoagulation Drug: Ranibizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Photocoagulation	Procedure	Photocoagulation include focal/grid laser and/or panretinal photocoagulation	Ranibizumab with Photocoagulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
best corrected visual acuity	Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.	every month, up to 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stable medication for the management of diabetes within 3 months
visual impairment due to focal or diffuse diabetic macula edema
decreased vision due to diabetic macula edema and not other causes

Exclusion Criteria:

concomitant conditions in the study eye that could prevent the improvement in VA on the study
active intraocular inflammation or infection in either eye
uncontrolled glaucoma in either eye
treatment with antiangiogenic drugs in the study eye within 3 months
history of stroke and uncontrolled hypertension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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 ou Ophthalmology Shinshu University School of Medicine		Matsumoto	Nagano	3908621	Japan

Intervention Browse Module

MeSH Terms

ID	Term
D008028	Light Coagulation
D000069579	Ranibizumab

Ancestor Terms

ID	Term
D006489	Hemostatic Techniques
D013812	Therapeutics
D006488	Hemostasis, Surgical
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided