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Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.

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ClinicalTrials.gov Identifier: NCT01707745
Recruitment Status : Unknown
Verified October 2012 by Sivakami A Pai, Dubai Health Authority.
Recruitment status was:  Recruiting
First Posted : October 16, 2012
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
Sivakami A Pai, Dubai Health Authority

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.


Condition or disease Intervention/treatment Phase
Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II. Procedure: Intravitreal Bevacizumab Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Avastin
Bevacizumab(Avastin) 0.75mg in 0.03 ml
Procedure: Intravitreal Bevacizumab
Other Name: Intravitreal Avastin



Primary Outcome Measures :
  1. Regression Of ROP [ Time Frame: Minimum 6 months follow up after intravitreal Avastin ]

Secondary Outcome Measures :
  1. Recurrence of ROP [ Time Frame: minimum 6 months of follow up. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   32 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707745


Contacts
Contact: Sivakami A Pai, MS, DNB, Phd 00971504148256
Contact: M A Dekhain, FRCS, MRCOpth 0097142195000 ext 6272 maDekhain@dha.gov.ae

Locations
United Arab Emirates
Dubai Hospital Recruiting
Dubai, UAE, United Arab Emirates
Contact: Sivakami A Pai, MS, DNB, Phd    00971504148256      
Contact: Moza A Dekhain, MRCOpthal, FRCS    009712195000 ext 6272    maDekhain@dha.gov.ae   
Principal Investigator: Sivakami A Pai, MS, DNB, Phd         
Sub-Investigator: Afra M Lootah, MSc, FRCS         
Sponsors and Collaborators
Sivakami A Pai

Responsible Party: Sivakami A Pai, Doctor, Dubai Health Authority
ClinicalTrials.gov Identifier: NCT01707745     History of Changes
Other Study ID Numbers: Avastin for threshold ROP.
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Retinopathy of Prematurity
Retinal Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents