Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
This study is currently recruiting participants.
Verified October 2012 by Dubai Health Authority
Sponsor:
Sivakami A Pai
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 22, 2012 | ||||||||
| Last Updated Date | October 15, 2012 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Regression Of ROP [ Time Frame: Minimum 6 months follow up after intravitreal Avastin ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01707745 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Recurrence of ROP [ Time Frame: minimum 6 months of follow up. ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP. | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II. | ||||||||
| Intervention ICMJE | Procedure: Intravitreal Bevacizumab
Other Name: Intravitreal Avastin |
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| Study Arm (s) | Avastin
Bevacizumab(Avastin) 0.75mg in 0.03 ml
Intervention: Procedure: Intravitreal Bevacizumab |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | 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. - |
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| Gender | Both | ||||||||
| Ages | 32 Weeks to 42 Weeks | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Arab Emirates | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01707745 | ||||||||
| Other Study ID Numbers ICMJE | Avastin for threshold ROP. | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Sivakami A Pai, Dubai Health Authority | ||||||||
| Study Sponsor ICMJE | Sivakami A Pai | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Dubai Health Authority | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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