Back to resultsEfficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
Primary Purpose
Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Intravitreal Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.
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.
-
Sites / Locations
- Dubai HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Avastin
Arm Description
Bevacizumab(Avastin) 0.75mg in 0.03 ml
Outcomes
Primary Outcome Measures
Regression Of ROP
Secondary Outcome Measures
Recurrence of ROP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01707745
Brief Title
Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sivakami A Pai
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Avastin
Arm Type
Other
Arm Description
Bevacizumab(Avastin) 0.75mg in 0.03 ml
Intervention Type
Procedure
Intervention Name(s)
Intravitreal Bevacizumab
Other Intervention Name(s)
Intravitreal Avastin
Primary Outcome Measure Information:
Title
Regression Of ROP
Time Frame
Minimum 6 months follow up after intravitreal Avastin
Secondary Outcome Measure Information:
Title
Recurrence of ROP
Time Frame
minimum 6 months of follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
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.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sivakami A Pai, MS, DNB, Phd
Phone
00971504148256
First Name & Middle Initial & Last Name or Official Title & Degree
M A Dekhain, FRCS, MRCOpth
Phone
0097142195000
Ext
6272
Email
maDekhain@dha.gov.ae
Facility Information:
Facility Name
Dubai Hospital
City
Dubai
State/Province
UAE
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sivakami A Pai, MS, DNB, Phd
Phone
00971504148256
First Name & Middle Initial & Last Name & Degree
Moza A Dekhain, MRCOpthal, FRCS
Phone
009712195000
Ext
6272
Email
maDekhain@dha.gov.ae
First Name & Middle Initial & Last Name & Degree
Sivakami A Pai, MS, DNB, Phd
First Name & Middle Initial & Last Name & Degree
Afra M Lootah, MSc, FRCS
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
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