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Effect of Intravitreal Anti-VEGF on Retinal Vessels Diameter

Primary Purpose

Age Related Macular Degeneration

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Intravitreal Ranibizumab
Intravitreal bevacizumab
Sponsored by
University of Malaya
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Age Related Macular Degeneration focused on measuring Anti vascular endothelial growth factor, retinal vessels

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Patients who wish and need bevacizumab or ranibizumab treatment for underlying disease

Exclusion Criteria:

  • History of previous systemic or ocular Anti-VEGF therapy
  • History of previous intravitreal injection with any drug
  • Intraocular pressure ≥ 22
  • Glaucoma
  • History or presence of thromboembolic events
  • Un-controlled blood pressure
  • Blood donation during the previous 3 weeks
  • Relevant media opacity of the lens

Sites / Locations

  • University of Malaya Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 20, 2012
Last Updated
June 21, 2012
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01626339
Brief Title
Effect of Intravitreal Anti-VEGF on Retinal Vessels Diameter
Official Title
Effect of Intravitreal Anti-Vascular Endothelial Growth Factors on Retinal Vessels Diameter
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will be recruited in this prospective self-controlled trial. Fundus photography will carried out at baseline immediately before injection and at 3, 7 days and 30 days after the first injection. Using image analysis software, measurements summarized as the central retinal artery equivalent (CRAE) and central retinal vein equivalent (CRVE). Null Hypothesis: There is no significant difference between arteriolar/venular diameter before and after injection of intravitreal ranibizumab/bevacizumab in the treated and untreated eye

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
Anti vascular endothelial growth factor, retinal vessels

7. Study Design

Study Phase
Not Applicable
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intravitreal Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Type
Drug
Intervention Name(s)
Intravitreal bevacizumab
Other Intervention Name(s)
Avastin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients who wish and need bevacizumab or ranibizumab treatment for underlying disease Exclusion Criteria: History of previous systemic or ocular Anti-VEGF therapy History of previous intravitreal injection with any drug Intraocular pressure ≥ 22 Glaucoma History or presence of thromboembolic events Un-controlled blood pressure Blood donation during the previous 3 weeks Relevant media opacity of the lens
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammadreza Peyman, MD
Phone
0060173387260
Ext
1
Email
drmpeyman@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Visvaraja Subrayan, Prof
Email
d.visva@hotmail.com
Facility Information:
Facility Name
University of Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammadreza Peyman, MD
Phone
0060173387260
Email
drmpeyman@yahoo.com

12. IPD Sharing Statement

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Effect of Intravitreal Anti-VEGF on Retinal Vessels Diameter

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