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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033031
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Stefan Sacu, 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.


Condition or disease Intervention/treatment Phase
Branch Retinal Vein Occlusion Drug: Lucentis intravitreal injection Drug: Avastin intravitreal injection Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment With Anti-vascular Endothelial Growth Factor in Patients With Branch Retinal Vein Occlusion: 5 Years of Clinical Experience
Study Start Date : August 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: Lucentis
PRN intravitreal injection of Lucentis
Drug: Lucentis intravitreal injection
Lucentis intravitreal injection

Active Comparator: Avastin
PRN intravitreal injection of Lucentis
Drug: Avastin intravitreal injection
Avastin intravitreal injection




Primary Outcome Measures :
  1. visual acuity [ Time Frame: up to 6 months ]
    measurement of visual acuity outcomes; baseline in comparison to long-term


Secondary Outcome Measures :
  1. retinal sensitivity [ Time Frame: up to 6 months ]
    course of retinal sensitivity within the groups

  2. central retinal thickness [ Time Frame: up to 6 months ]
    course of central retinal thickness

  3. treatment rate [ Time Frame: up to 6 months ]
    treatment rate within the groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Macular edema secondary to Branch retinal vein occlusion

Exclusion Criteria:

  • Aphakia, Glaucoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033031


Locations
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Austria
Medical University of Vienna
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Stefan Sacu, Prof. Medical University of Vienna, Department of Ophthalmology and Optometry
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Responsible Party: Stefan Sacu, Prof. Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02033031    
Other Study ID Numbers: 1-Sacu
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Stefan Sacu, Medical University of Vienna:
branch retinal vein occlusion
central retinal thickness
visual acuity
central reintal sensitivity
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ranibizumab
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors