Major and Macular Branched Retinal Venous Occlusion

Sponsor

Hallym University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01219205

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Procedure: intravitreal bevacizumab	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Aug 1, 2010

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

efficacy of intravitreal bevacizumab [baseline and 12 months after initial injection]
the number on intravitreal bevacizumab during follow-up

Secondary Outcome Measures

cytokine levels in aqueous humor [before intravitreal injection]
cytokine levels in aqueous humor before bevacizumab injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ji Won Lim	Chuncheon-si	Kangwon-do	Korea, Republic of	200-704

Sponsors and Collaborators

Hallym University Medical Center

Investigators

Study Chair: Ji Won Lim, Prof, Hallym Medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01219205

Other Study ID Numbers:

2009_128

First Posted:

Oct 13, 2010

Last Update Posted:

Oct 13, 2010

Last Verified:

Oct 1, 2010

Keywords provided by , ,

macular edema secondary to retinal benous occlusion

Additional relevant MeSH terms:

Macular Edema

Edema

Bevacizumab

Study Results

No Results Posted as of Oct 13, 2010