Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on macular edema secondary to branch retinal vein occlusion

UMIN ID: UMIN000001546

Registered date:02/12/2008

Basic Information

• Health condition(s) or Problem(s) studied: Macular edema secondary to branch retinal vein occlusion
• Date of first enrollment: 2006/10/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

duration: 12 months quantity: bevacizumab 1.25 mg number: no addition injection 3 months after primary injection and addition injection if the visual acuity decrease or the central retinal thicknes increase more than 100 micro meter.
duration: 12 months quantity: triamcinolone acetonide 20 mg number: no addition injection 3 months after primary injection and addition injection if the visual acuity decrease or the central retinal thicknes increase more than 100 micro meter.

Outcome(s)

• Primary Outcome: variation on a logarithm of the minimum angle of resolution and variation on a central retinal thickness 1 month, 3 months, 6 months, 9 months, and 12 months after intravitreal injection.
• Secondary Outcome: fluorescin angiography before and 1 month, 3 months, 6 months, 9 months, and 12 months after intravitreal injection.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: glaucoma ocular pressure more than 21 mmHg inflammation disease diabetic retinopathy history of steroid therapy

Related Information

• Primary Sponsor: Shiga University of Medical Science, department of Ophthalmology
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology