Effect of Intravitreal Anti-VEGF on Retinal Vessels Diameter

Age Related Macular Degeneration Clinical Trial

Official title:

Effect of Intravitreal Anti-Vascular Endothelial Growth Factors on Retinal Vessels Diameter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01626339
• Other study ID #: PPUM/MDU/300/04/03
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2012
• Last updated: June 21, 2012
• Start date: April 2012

Study information

• Verified date: June 2012
• Source: University of Malaya
• Contact: Mohammadreza Peyman, MD
• Phone: 0060173387260
• Email: drmpeyman[@]yahoo.com
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Intravitreal Ranibizumab

• Intravitreal bevacizumab

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia,