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

Study Overview
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Brief Summary
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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
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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

Official Title
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Treatment With Anti-vascular Endothelial Growth Factor in Patients With Branch Retinal Vein Occlusion: 5 Years of Clinical Experience

Conditions
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Branch Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Lucentis intravitreal injection
* Drug: Avastin intravitreal injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Macular edema secondary to Branch retinal vein occlusion Exclusion Criteria: Aphakia, Glaucoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lucentis<br>PRN intravitreal injection of Lucentis | Drug: Lucentis intravitreal injection<br>* Lucentis intravitreal injection<br>|
| Active Comparator: Avastin<br>PRN intravitreal injection of Lucentis | Drug: Avastin intravitreal injection<br>* Avastin intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | measurement of visual acuity outcomes; baseline in comparison to long-term | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal sensitivity | course of retinal sensitivity within the groups | up to 6 months | 
| central retinal thickness | course of central retinal thickness | up to 6 months | 
| treatment rate | treatment rate within the groups | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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branch retinal vein occlusion, central retinal thickness, visual acuity, central reintal sensitivity