A Phase 3 interventional study of Lucentis intravitreal injection and Avastin intravitreal injection in Branch Retinal Vein Occlusion, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.
Sponsored by Medical University of Vienna · Phase 3, Interventional, and Treatment
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.
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
282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.
This study's enrollment of 28 is below the median of 49 across 211 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
PRN intravitreal injection of Lucentis
Drug: Lucentis intravitreal injection
PRN intravitreal injection of Lucentis
Drug: Avastin intravitreal injection
Lucentis intravitreal injection
Avastin intravitreal injection
visual acuity
measurement of visual acuity outcomes; baseline in comparison to long-term
Time frame: up to 6 months
retinal sensitivity
course of retinal sensitivity within the groups
Time frame: up to 6 months
central retinal thickness
course of central retinal thickness
Time frame: up to 6 months
treatment rate
treatment rate within the groups
Time frame: up to 6 months
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna