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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02033031
Collaborator
(none)
28
1
2
6
4.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Design

Study Type:
Interventional
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 :
Aug 1, 2012
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. visual acuity [up to 6 months]

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

Secondary Outcome Measures

  1. retinal sensitivity [up to 6 months]

    course of retinal sensitivity within the groups

  2. central retinal thickness [up to 6 months]

    course of central retinal thickness

  3. treatment rate [up to 6 months]

    treatment rate within the groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Macular edema secondary to Branch retinal vein occlusion
Exclusion Criteria:
  • Aphakia, Glaucoma

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Stefan Sacu, Prof., Medical University of Vienna, Department of Ophthalmology and Optometry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stefan Sacu, Prof. Dr, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02033031
Other Study ID Numbers:
  • 1-Sacu
First Posted:
Jan 10, 2014
Last Update Posted:
Jan 10, 2014
Last Verified:
Jan 1, 2014
Keywords provided by Stefan Sacu, Prof. Dr, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2014