CClinicalTrials.gg
CompletedNCT02033031Updated Jan 10, 2014

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

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

Phase
Phase 3
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Branch Retinal Vein Occlusion

Keywords

  • branch retinal vein occlusion
  • central retinal thickness
  • visual acuity
  • central reintal sensitivity
03

In context

Retinal Vein Occlusion

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 →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Macular edema secondary to Branch retinal vein occlusion

Exclusion criteria

Exclusion Criteria:

  • Aphakia, Glaucoma
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Active comparator
    Lucentis

    PRN intravitreal injection of Lucentis

    Drug: Lucentis intravitreal injection

  • Active comparator
    Avastin

    PRN intravitreal injection of Lucentis

    Drug: Avastin intravitreal injection

Interventions

  • DrugLucentis intravitreal injection

    Lucentis intravitreal injection

  • DrugAvastin intravitreal injection

    Avastin intravitreal injection

06

What researchers measure

Primary outcomes

  1. visual acuity

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

    Time frame: up to 6 months

Secondary outcomes

  1. retinal sensitivity

    course of retinal sensitivity within the groups

    Time frame: up to 6 months

  2. central retinal thickness

    course of central retinal thickness

    Time frame: up to 6 months

  3. treatment rate

    treatment rate within the groups

    Time frame: up to 6 months

07

Study locations

1 site
  • Medical University of Vienna
    Vienna, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02033031
Lead sponsor
Medical University of Vienna
Responsible party
Stefan Sacu (Prof. Dr, Medical University of Vienna) — Principal investigator
First posted
Jan 10, 2014
Start date
Aug 2012
Primary completion
Nov 2012
Completion
Feb 2013
Last update
Jan 10, 2014

Study contacts

Stefan Sacu, Prof.
principal investigator · Medical University of Vienna, Department of Ophthalmology and Optometry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion