Major and Macular Branched Retinal Venous Occlusion

Macular Edema Clinical Trial

Official title:

Intravitreal Bevacizumab for Macular Edema Secondary to Major and Macular Branch Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219205
• Other study ID #: 2009_128
• Status: Completed
• Phase: N/A
• First received: October 10, 2010
• Last updated: October 12, 2010
• Start date: March 2008
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: Hallym University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Although it is important in the clinical management to classify BRVO into subtypes based on the location of the occlusion (major or macular), few studies have provided such information[8,9]. The aim of this study was to evaluate the outcome of patients with macular edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab injection and to determine the concentrations of cytokines in the aqueous humor according to the site of the occlusion.

Description:

Branch retinal vein occlusion is the second most frequent major retinal vascular disease after diabetic retinopathy. One of the main reasons for visual loss in BRVO is the development of macular edema. Treatment options for BRVO include grid laser treatment, intravitreal injection of steroids, surgical procedures, and off-label treatment with intravitreal anti-vascular endothelial growth factor (VEGF) agents. During recent years, intravitreal anti-VEGF treatment with bevacizumab has been shown to efficiently reduce macular edema and improve visual acuity in numerous case series and prospective or retrospective studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• macular edema involving the center of the fovea with a minimum central macular thickness at baseline of =250 µm

Exclusion Criteria:

• previous vitreoretinal surgery, intravitreal injections or laser treatment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Edema

Intervention

Procedure:
• intravitreal bevacizumab
Intravitreal injections of bevacizumab were performed under sterile conditions in the operating room. a 27-gauge needle was inserted through the corneal limbus to withdraw 0.05 ml of aqueous humor and soften the globe. Then, 1.25 mg (0.05 ?) of bevacizumab was injected into the vitreous in the superior temporal quadrant with a 30-gauge needle that was inserted into the eye 3.5 mm from the limbus. The postoperative medications included topical antibiotics.

Locations

Country	Name	City	State
Korea, Republic of	Ji Won Lim	Chuncheon-si	Kangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of intravitreal bevacizumab	the number on intravitreal bevacizumab during follow-up	baseline and 12 months after initial injection	Yes
Secondary	cytokine levels in aqueous humor	cytokine levels in aqueous humor before bevacizumab injection	before intravitreal injection	Yes