Long-term Treatment Effect of Intravitreal Ant-VEGF in Branch Retinal Vein Occlusion

Phase 3

Completed

• Conditions: Branch Retinal Vein Occlusion
• Interventions: Drug: Avastin intravitreal injection; Drug: Lucentis intravitreal injection

• Registration Number: NCT02033031
• Lead Sponsor: Medical University of Vienna

Brief Summary

Retinal vein occlusion (RVO) is the second leading cause of retinal vascular disease in patients older than 50 years.The prevalence varies from 0.7% to 1.6% in the literature.

Visual recovery depends on ischemic damage of the retina, the occurence of macular edema (ME) and the development of neovascular glaucoma. The occurence of ME is the main reason for visual loss and frustrates visual recovery among patients with both central or branch RVO.

Therapeutic options that have been used and discussed over the years are the treatment with anticoagulants, fibrinolytics, corticosteroids, acetazolamide and isovolemic haemodilution. Furthermore, surgical options like vitrectomy and radial optic neurotomy were used. Panretinal photocoagulation and grid pattern photocoagulation had established as additional tool to induce chorioretinal anastomosis. Nevertheless, the effectiveness and the evidence of these different treatment options could not be verified and remains mostly unknown.

Nowadays, intravitreal anti-VEGF application had become the treatment of choice for ME secondary to RVO. Multi-center studies have already shown the effectiveness of anti-VEGF treatment to reduce intraretinal fluid and retinal hemorrhages (BRAVO, CRUISE). Unfortunately, often high numbers of re-treatments become necessary over the years. In our knowledge, there are no reports showing more than 3 years treatment effects of antiangiogenic drugs in patients with BRVO. However, the results of treatment effect longer than 3 years are important, as the mean age \< 70 years with an onset of BRVO has been estimated in about 60% of all cases. In addition, most patients with regard to the application of anti-VEGF treatment in real clinical setting, there is only rare experience concerning need of optimum time duration for follow-up at the departments. Hence, the present study aimed to evaluate the long-term clinical outcomes, safety and therapeutic benefit of a flexible dosing regimen of intravitreal anti-VEGF therapy in patients with ME secondary to BRVO.

Detailed Description

This cross-sectional study evaluates a series of patients with ME due to RVO who were available for at least 4 years' follow-up examination. The patients received either intravitreal ranibizumab (IVR) or bevacizumab (IVB) in a flexible dosing regimen

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-11
• Study Completion: 2013-02
• Status Verified: 2014-01
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Macular edema secondary to Branch retinal vein occlusion

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Exclusion Criteria

• Aphakia, Glaucoma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avastin	Avastin intravitreal injection	PRN intravitreal injection of Lucentis
Lucentis	Lucentis intravitreal injection	PRN intravitreal injection of Lucentis

Primary Outcome Measures

Name	Time	Method
visual acuity	up to 6 months	measurement of visual acuity outcomes; baseline in comparison to long-term

Secondary Outcome Measures

Name	Time	Method
retinal sensitivity	up to 6 months	course of retinal sensitivity within the groups
central retinal thickness	up to 6 months	course of central retinal thickness
treatment rate	up to 6 months	treatment rate within the groups

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria