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

Primary Purpose

Branch Retinal Vein Occlusion

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Lucentis intravitreal injection
Avastin intravitreal injection
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring branch retinal vein occlusion, central retinal thickness, visual acuity, central reintal sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Macular edema secondary to Branch retinal vein occlusion

Exclusion Criteria:

  • Aphakia, Glaucoma

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lucentis

Avastin

Arm Description

PRN intravitreal injection of Lucentis

PRN intravitreal injection of Lucentis

Outcomes

Primary Outcome Measures

visual acuity
measurement of visual acuity outcomes; baseline in comparison to long-term

Secondary Outcome Measures

retinal sensitivity
course of retinal sensitivity within the groups
central retinal thickness
course of central retinal thickness
treatment rate
treatment rate within the groups

Full Information

First Posted
January 2, 2014
Last Updated
January 9, 2014
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02033031
Brief Title
Long-term Treatment Effect of Intravitreal Ant-VEGF in Branch Retinal Vein Occlusion
Official Title
Treatment With Anti-vascular Endothelial Growth Factor in Patients With Branch Retinal Vein Occlusion: 5 Years of Clinical Experience
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion
Keywords
branch retinal vein occlusion, central retinal thickness, visual acuity, central reintal sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lucentis
Arm Type
Active Comparator
Arm Description
PRN intravitreal injection of Lucentis
Arm Title
Avastin
Arm Type
Active Comparator
Arm Description
PRN intravitreal injection of Lucentis
Intervention Type
Drug
Intervention Name(s)
Lucentis intravitreal injection
Intervention Description
Lucentis intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Avastin intravitreal injection
Intervention Description
Avastin intravitreal injection
Primary Outcome Measure Information:
Title
visual acuity
Description
measurement of visual acuity outcomes; baseline in comparison to long-term
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
retinal sensitivity
Description
course of retinal sensitivity within the groups
Time Frame
up to 6 months
Title
central retinal thickness
Description
course of central retinal thickness
Time Frame
up to 6 months
Title
treatment rate
Description
treatment rate within the groups
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Macular edema secondary to Branch retinal vein occlusion Exclusion Criteria: Aphakia, Glaucoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Sacu, Prof.
Organizational Affiliation
Medical University of Vienna, Department of Ophthalmology and Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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