NCT01707745

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.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration 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

January 1, 2010

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

2.9 years

First QC Date

September 22, 2012

Last Update Submit

October 15, 2012

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Regression Of ROP

    Minimum 6 months follow up after intravitreal Avastin

Secondary Outcomes (1)

  • Recurrence of ROP

    minimum 6 months of follow up.

Study Arms (1)

Avastin

OTHER

Bevacizumab(Avastin) 0.75mg in 0.03 ml

Procedure: Intravitreal Bevacizumab

Interventions

Intravitreal BevacizumabPROCEDURE
Also known as: Intravitreal Avastin
Avastin

Eligibility Criteria

Age32 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Informed written consent by parents or guardian.

You may not qualify if:

  • Refusal to give consent Critically ill neonates.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dubai Hospital

Dubai, UAE, United Arab Emirates

RECRUITING

Central Study Contacts

Sivakami A Pai, MS, DNB, Phd

CONTACT

00971504148256

M A Dekhain, FRCS, MRCOpth

CONTACT

0097142195000maDekhain@dha.gov.ae

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 22, 2012

First Posted

October 16, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations

AE(1)