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

NCT02033031 | Completed Phase 3

• 1 other identifier: 1-Sacu
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Branch Retinal Vein Occlusion

Keywords

branch retinal vein occlusion; central retinal thickness; visual acuity; central reintal sensitivity

Outcome Measures

Primary Outcomes (1)

• visual acuity

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

  up to 6 months

Secondary Outcomes (3)

• retinal sensitivity

  up to 6 months

• central retinal thickness

  up to 6 months

• treatment rate

  up to 6 months

Study Arms (2)

Lucentis

ACTIVE COMPARATOR

PRN intravitreal injection of Lucentis

Drug: Lucentis intravitreal injection

Avastin

ACTIVE COMPARATOR

PRN intravitreal injection of Lucentis

Drug: Avastin intravitreal injection

Interventions

Lucentis intravitreal injection DRUG

Lucentis intravitreal injection

Lucentis

Avastin intravitreal injection DRUG

Avastin intravitreal injection

Avastin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Macular edema secondary to Branch retinal vein occlusion

You may not qualify if:

• Aphakia, Glaucoma

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

Ranibizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stefan Sacu, Prof.

  Medical University of Vienna, Department of Ophthalmology and Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: January 2, 2014
• First Posted: January 10, 2014
• Study Start: August 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

AU (1)