- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01707745
Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
October 15, 2012 updated by: Sivakami A Pai
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sivakami A Pai, MS, DNB, Phd
- Phone Number: 00971504148256
Study Contact Backup
- Name: M A Dekhain, FRCS, MRCOpth
- Phone Number: 6272 0097142195000
- Email: maDekhain@dha.gov.ae
Study Locations
-
-
UAE
-
Dubai, UAE, United Arab Emirates
- Recruiting
- Dubai Hospital
-
Contact:
- Sivakami A Pai, MS, DNB, Phd
- Phone Number: 00971504148256
-
Contact:
- Moza A Dekhain, MRCOpthal, FRCS
- Phone Number: 6272 009712195000
- Email: maDekhain@dha.gov.ae
-
Principal Investigator:
- Sivakami A Pai, MS, DNB, Phd
-
Sub-Investigator:
- Afra M Lootah, MSc, FRCS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 9 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Avastin
Bevacizumab(Avastin) 0.75mg in 0.03 ml
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Regression Of ROP
Time Frame: Minimum 6 months follow up after intravitreal Avastin
|
Minimum 6 months follow up after intravitreal Avastin
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence of ROP
Time Frame: minimum 6 months of follow up.
|
minimum 6 months of follow up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
September 22, 2012
First Submitted That Met QC Criteria
October 15, 2012
First Posted (Estimate)
October 16, 2012
Study Record Updates
Last Update Posted (Estimate)
October 16, 2012
Last Update Submitted That Met QC Criteria
October 15, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Infant, Newborn, Diseases
- Retinal Diseases
- Infant, Premature, Diseases
- Retinopathy of Prematurity
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- Avastin for threshold ROP.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Grade 3 Follicular Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone... and other conditionsUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone Lymphoma | Waldenstrom Macroglobulinemia | Cutaneous B-cell Non-Hodgkin Lymphoma and other conditionsUnited States
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National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Grade 3 Follicular Lymphoma and other conditionsUnited States
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Case Comprehensive Cancer CenterTerminatedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
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National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Splenic Marginal Zone Lymphoma | Waldenström Macroglobulinemia and other conditionsUnited States
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult... and other conditionsUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Genentech, Inc.; Pharmacyclics LLC.RecruitingNon-Hodgkin's Lymphoma | Indolent Non-hodgkin Lymphoma | Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage II Follicular Lymphoma | Ann Arbor Stage II Nodal Marginal Zone Lymphoma | Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma | Ann Arbor... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
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Cairo UniversityTerminatedDiabetic Retinopathy | Diabetic Macular Edema | Vascular Endothelial Growth Factor Overexpression | Macular IschemiaEgypt
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Panhandle Eye Group, LLPCompletedDiabetic RetinopathyMexico
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University of MalayaUnknownAge Related Macular DegenerationMalaysia
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Barnes Retina InstituteMassachusetts Eye and Ear Infirmary; Long Island Vitreoretinal Consultants; Illinois... and other collaboratorsCompletedMacular Edema | Retinal Vein OcclusionUnited States
-
Asociación para Evitar la Ceguera en MéxicoCompletedChoroidal Neovascularization | Diabetic Proliferative Retinopathy | Vascular Vein Oclussion