Major and Macular Branched Retinal Venous Occlusion

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

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema
• Intervention / Treatment: Procedure: intravitreal bevacizumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kangwon-do
    • Chuncheon-si, Kangwon-do, Korea, Republic of, 200-704
      • Ji Won Lim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: major branched retinal venous occlusion	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.
Active Comparator: macular branched retinal venous occlusion	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of intravitreal bevacizumab	the number on intravitreal bevacizumab during follow-up	baseline and 12 months after initial injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cytokine levels in aqueous humor	cytokine levels in aqueous humor before bevacizumab injection	before intravitreal injection

Collaborators and Investigators

• Sponsor: Hallym University Medical Center
• Investigators: Study Chair: Ji Won Lim, Prof, Hallym Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: October 10, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 12, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: macular edema secondary to retinal benous occlusion
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: 2009_128