Ranibizumab for Diabetic Traction Retinal Detachment | NCT01201161

Studies
Ranibizumab for Diabetic Traction Retinal Detachment

NCT01201161

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

Sep 14, 2010Estimated

Enrollment

19Actual

Phase

Phase 2

Conditions

Diabetic Retinopathy
Retinal Detachment

Interventions

Ranibizumab
Sham injection

Countries

Brazil

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

Jan 2010

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

Dec 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Sep 13, 2010

First Submission Date that Met QC Criteria

Sep 13, 2010

First Posted Date

Sep 14, 2010Estimated

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 13, 2010

Last Update Posted Date

Sep 14, 2010Estimated

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

The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RANI/PPV	Experimental	Preoperative intravitreal ranibizumab and pars plana vitrectomy	Drug: Ranibizumab
PPV	Placebo Comparator	Sham injection and pars plana vitrectomy	Other: Sham injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab	Drug	Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy	RANI/PPV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amount of intraoperative intra-ocular bleeding	amount of intra-ocular bleeding that occurred during pars plana vitrectomy	one week

Secondary Outcomes

Measure	Description	Time Frame
visual acuity	ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria:

Massive vitreous hemorrhage preventing from detailed posterior pole examination;
Previous intra-ocular surgery other than cataract surgery
Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
Prothrombin time, partial thromboplastin time or platelet count without normal limits
History of previous thromboembolic events

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodrigo Jorge, MD, PhD	University of Sao Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of São Paulo		Ribeirão Preto	São Paulo	14048-900	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy
D012163	Retinal Detachment
D014823	Vitreous Hemorrhage

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab
C005703	salicylhydroxamic acid

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided