Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Dubai Health Authority.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sivakami A Pai, Dubai Health Authority
ClinicalTrials.gov Identifier:
NCT01707745
First received: September 22, 2012
Last updated: October 15, 2012
Last verified: October 2012

September 22, 2012
October 15, 2012
January 2010
December 2012   (final data collection date for primary outcome measure)
Regression Of ROP [ Time Frame: Minimum 6 months follow up after intravitreal Avastin ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01707745 on ClinicalTrials.gov Archive Site
Recurrence of ROP [ Time Frame: minimum 6 months of follow up. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
Not Provided

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.
Procedure: Intravitreal Bevacizumab
Other Name: Intravitreal Avastin
Avastin
Bevacizumab(Avastin) 0.75mg in 0.03 ml
Intervention: Procedure: Intravitreal Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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.

-

Both
32 Weeks to 42 Weeks
No
Contact: Sivakami A Pai, MS, DNB, Phd 00971504148256
Contact: M A Dekhain, FRCS, MRCOpth 0097142195000 ext 6272 maDekhain@dha.gov.ae
United Arab Emirates
 
NCT01707745
Avastin for threshold ROP.
Yes
Sivakami A Pai, Dubai Health Authority
Sivakami A Pai
Not Provided
Not Provided
Dubai Health Authority
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP