Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion

Not Applicable

Completed

• Conditions: Branch Retinal Vein Occlusion

• Registration Number: NCT01614509
• Lead Sponsor: Yeungnam University College of Medicine

Brief Summary

This study compares the efficacy of intravitreal bevacizumab monotherapy only or combined therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the treatment of macular edema associated with branch retinal vein occlusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2012-08-31
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-03
• Last Update Submitted: 2012-12-03
• Results First Posted: 2012-12-04
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. The participant must have macular edema associated branch retinal vein occlusion.
2. The participant has retinal photographs, optical coherence tomography (OCT) and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice.
3. The participant must be willing and able to comply with the protocol.

Exclusion Criteria

1. The participant has BRVO with other ocular vascular diseases such as central retinal vein occlusion, hypertensive retinopathy, etc.
2. The participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
3. The participant has a history of treatment for BRVO in the study eye with focal laser photocoagulation, intravitreal triamcinolone acetonide injection or intravitreal Bevacizumab injection
4. The participant has a history of intraocular surgery (including lens replacement surgery).
5. The participant has a history of ocular trauma, or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of Central Retinal Thickness	baseline, 1, 3, 6 months after injection	Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection

Secondary Outcome Measures

Name	Time	Method
Additional Intravitreal Bevacizumab Injection	6 months	Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months

Trial Locations

Locations (1)

Yeungnam University College of Medicine; 🇰🇷 Daegu, Korea, Republic of