Long-term Treatment Effect of Intravitreal Ant-VEGF in Branch Retinal Vein Occlusion
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Branch Retinal Vein Occlusion
Intervention: Lucentis intravitreal injection (Drug); Avastin intravitreal injection (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s): Stefan Sacu, Prof., Principal Investigator, Affiliation: Medical University of Vienna, Department of Ophthalmology and Optometry
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.
Clinical Details
Official title: Treatment With Anti-vascular Endothelial Growth Factor in Patients With Branch Retinal Vein Occlusion: 5 Years of Clinical Experience
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: visual acuity
Secondary outcome: retinal sensitivitycentral retinal thickness treatment rate
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Macular edema secondary to Branch retinal vein occlusion
Exclusion Criteria:
- Aphakia, Glaucoma
Locations and Contacts
Medical University of Vienna, Vienna, Austria
Additional Information
Starting date: August 2012
Last updated: January 9, 2014
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