Efficacy and Safety of Intravitreal Bevacizumab for Thres... | NCT01707745

Studies
Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

NCT01707745

Sponsor

Sivakami A Pai

Status

Unknown status

Last Update Posted

Oct 16, 2012Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.

Interventions

Intravitreal Bevacizumab

Countries

United Arab Emirates

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

Oct 2012

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

Jan 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Sep 22, 2012

First Submission Date that Met QC Criteria

Oct 15, 2012

First Posted Date

Oct 16, 2012Estimated

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

Oct 15, 2012

Last Update Posted Date

Oct 16, 2012Estimated

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

Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP).

Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Avastin	Other	Bevacizumab(Avastin) 0.75mg in 0.03 ml	Procedure: Intravitreal Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal Bevacizumab	Procedure		Avastin	Intravitreal Avastin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Regression Of ROP		Minimum 6 months follow up after intravitreal Avastin

Secondary Outcomes

Measure	Description	Time Frame
Recurrence of ROP		minimum 6 months of follow up.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: stage 2+ or stage 3+ Retinopathy of prematurity in Zone I or Zone II.

Informed written consent by parents or guardian.

Exclusion Criteria:

Refusal to give consent Critically ill neonates.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

32 Weeks

Maximum Age

42 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sivakami A Pai, MS, DNB, Phd	Contact	00971504148256
M A Dekhain, FRCS, MRCOpth	Contact	0097142195000	6272	maDekhain@dha.gov.ae

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dubai Hospital	Recruiting	Dubai	UAE		United Arab Emirates